{"id":"testosterone","rwe":[],"_fda":{"id":"0a13cf12-e51e-4d3d-a7c4-ea74712e6db2","set_id":"03b9c0b1-5884-11e4-8ed6-0800200c9a66","openfda":{"nui":["N0000175824","N0000000146","M0001109"],"unii":["3XMK78S47O"],"route":["SUBCUTANEOUS"],"rxcui":["318240","404405"],"spl_id":["0a13cf12-e51e-4d3d-a7c4-ea74712e6db2"],"brand_name":["Testopel"],"spl_set_id":["03b9c0b1-5884-11e4-8ed6-0800200c9a66"],"package_ndc":["66887-004-01","66887-004-10","66887-004-20"],"product_ndc":["66887-004"],"generic_name":["TESTOSTERONE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Androstanes [CS]"],"substance_name":["TESTOSTERONE"],"pharm_class_epc":["Androgen [EPC]"],"pharm_class_moa":["Androgen Receptor Agonists [MoA]"],"manufacturer_name":["Endo USA, Inc."],"application_number":["ANDA080911"],"is_original_packager":[true]},"version":"28","warnings":["WARNINGS In patients with breast cancer, androgen therapy may cause hypercalcemia by stimulating osteolysis. In this case, the drug should be discontinued. Prolonged use of high doses of androgens has been associated with the development of peliosis hepatis and hepatic neoplasms including hepatocellular carcinoma (see PRECAUTIONS - Carcinogenesis, Mutagenesis, Impairment of Fertility). Peliosis hepatis can be a life-threatening or fatal complication. Men treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma. There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as TESTOPEL ® (testosterone pellets). Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with TESTOPEL ® (testosterone pellets) and initiate appropriate workup and management (see ADVERSE REACTIONS ). Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use TESTOPEL ® (testosterone pellets). Testosterone can increase blood pressure which can increase cardiovascular (CV) risk over time. Monitor blood pressure periodically in men using testosterone products, especially in men with hypertension. Testosterone products are not recommended for use in patients with uncontrolled hypertension. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions (see DRUG ABUSE AND DEPENDENCE ) . If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. Gynecomastia frequently develops in patients and occasionally persists in patients being treated for hypogonadism. Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height. Post-marketing cases associate TESTOPEL ® pellet(s) insertion with implant site infection (cellulitis and abscess), and/or pellet extrusion at or near the implantation site. Infection and extrusion may occur concurrently or separately. Reported signs and symptoms of infection and/or extrusion at the implant site included induration, inflammation, fibrosis, bleeding, bruising, wound drainage, pain, itching, and pellet extrusion. Although cases of infection and/or extrusion may occur at any time, most reported cases occurred within the first month after TESTOPEL ® implantation. Infection and/or extrusion may require further treatment (see ADVERSE REACTIONS). This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk for serious adverse health effects, this drug should not be used for such purpose."],"overdosage":["OVERDOSAGE There have been no reports of acute overdosage with the androgens."],"description":["DESCRIPTION TESTOPEL ® (testosterone pellets) are cylindrically shaped pellets 3.2mm (1/8 inch) in diameter and approximately 9mm in length. Each sterile pellet weighs approximately 78mg (75mg testosterone) and is ready for implantation. Androgens are steroids that develop and maintain primary and secondary male sex characteristics. Testosterone is a member of this class. Structural formula for testosterone follows: INGREDIENTS Each TESTOPEL ® (testosterone pellets) for subcutaneous implantation contains 75mg testosterone. In addition each pellet contains the following inactive ingredients: stearic acid NF 0.97mg and polyvinylpyrrolidone USP 2mg. TESTOPEL ® (testosterone pellets) consist of crystalline testosterone. When implanted subcutaneously, the pellets slowly release the hormone for a long acting androgenic effect. this is an image of the chemical structure for testosterone."],"precautions":["PRECAUTIONS GENERAL Pellet implantation is much less flexible for dosage adjustment than is oral administration of or intramuscular injections of oil solutions or aqueous suspensions. Therefore, great care should be used when estimating the amount of testosterone needed. In the face of complications where the effects of testosterone should be discontinued, the pellets would have to be removed. INFORMATION FOR THE PATIENT The physician should instruct patients to report any of the following side effects of androgens: Adult or adolescent males: Too frequent or persistent erections of the penis. Any nausea, vomiting, changes in skin color, ankle swelling. Implantation site infection and/or pellet extrusion can occur and may be associated with implant site induration, inflammation, fibrosis, bleeding, bruising, wound drainage, pain, itching, and pellet extrusion. (see WARNINGS and ADVERSE REACTIONS). Any male adolescent patient receiving androgens for delayed puberty should have bone development checked every 6 months. LABORATORY TESTS Because of the hepatotoxicity associated with the use of 17-alpha-alkylated androgens, liver function tests should be obtained periodically. Periodic (every 6 months) x-ray examinations of the bone age should be made during treatment of prepubertal males to determine the rate of bone maturation and the effects of androgen therapy on the epiphyseal centers. Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of androgens. DRUG INTERACTIONS Anticoagulants. C-17 substituted derivatives of testosterone, such as methandrostenolone have been reported to decrease the anticoagulant requirements of patients receiving oral anticoagulants. Patients receiving oral anticoagulant therapy require close monitoring, especially when androgens are started or stopped. Oxyphenbutazone. Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone. Insulin. In diabetic patients the metabolic effects of androgens may decrease blood glucose and insulin requirements. DRUG/LABORATORY TEST INTERFERENCES Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY Animal Data. Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of liver in rats. Human Data. There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma. PREGNANCY Teratogenic Effects. Pregnancy Category X (see CONTRAINDICATIONS). NURSING MOTHERS It is not known whether androgens are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from androgens, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. PEDIATRIC USE Androgen therapy should be used very cautiously in children and only by specialists who are aware of the adverse effects on bone maturation. Skeletal maturation must be monitored every 6 months by an x-ray of the hand and wrist (see INDICATIONS AND USAGE and WARNINGS )."],"how_supplied":["HOW SUPPLIED Testosterone pellets each containing 75mg testosterone. One pellet per vial in boxes of 10 (NDC: 66887-004-10) and 100 (NDC: 66887-004-20). Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Rx Only Manufactured for: Endo USA Malvern, PA 19355 © 2025 Endo, Inc. or one of its affiliates. Revised 07/2025"],"effective_time":"20250717","adverse_reactions":["ADVERSE REACTIONS The following adverse reactions have been identified during post-approval use of testosterone replacement therapy, including TESTOPEL ® . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Implantation Site Infection and Pellet Extrusion: (see WARNINGS) Endocrine and Urogenital, Male. Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages (see CLINICAL PHARMACOLOGY ). Skin and Appendages. Hirsutism, male pattern of baldness, and acne. Cardiovascular Disorders. Myocardial infarction, stroke. Fluid and Electrolyte Disturbances. Retention of sodium, chloride, water, potassium, calcium and inorganic phosphates. Gastrointestinal. Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS ). Hematologic. Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia. Nervous System. Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. Metabolic. Increased serum cholesterol. Vascular Disorders: Venous thromboembolism (see WARNINGS ). Miscellaneous. Rarely anaphylactoid reactions."],"contraindications":["CONTRAINDICATIONS Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate. If administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. The virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. The degree of masculinization is related to the amount of drug given and the age of the fetus, and is most likely to occur in the female fetus when the drugs are given in the first trimester. If the patient becomes pregnant while taking these drugs she should be apprised of the potential hazard to the fetus."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Endogenous androgens are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution such as beard, pubic, chest and axillary hair, laryngeal enlargements, vocal cord thickening, alterations in body musculature and fat distribution. Drugs in this class can also cause retention of nitrogen, sodium, potassium, phosphorus, and decreased urinary excretion of calcium. Androgens have been reported to increase protein anabolism and decrease protein catabolism. Nitrogen balance is improved only when there is sufficient intake of calories and protein. Androgens are responsible for the growth spurt of adolescence and for the eventual termination of linear growth which is brought about by the fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates, but may cause a disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of growth process. Androgens have been reported to stimulate the production of red blood cells by enhancing the production of erythropoietic stimulating factor. During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH). There is a lack of substantial evidence that androgens are effective in fractures, surgery, convalescence, and functional uterine bleeding. PHARMACOKINETICS Testosterone in plasma is 98 percent bound to a specific testosterone-estradiol binding globulin, and about 2 percent is free. Generally, the amount of this sex-hormone binding globulin in the plasma will determine the distribution of testosterone between the free and bound forms, and the free testosterone concentration will determine its half-life. About 90 percent of a dose of testosterone is excreted as glucuronic and sulfuric acid conjugates of testosterone and its metabolites; about 6 percent of a dose is excreted in feces, mostly in the unconjugated form. Inactivation of testosterone occurs primarily in the liver. Testosterone is metabolized to various 17-keto steroids through two different pathways. There are considerable variations of the half-life as reported in the literature, ranging from 10-100 minutes. In many tissues the activity of testosterone appears to depend on reduction to dihydrotestosterone, which binds to cytosol receptor proteins. The steroid-receptor complex is transported to the nucleus where it initiates transcription events and cellular changes related to androgen action."],"indications_and_usage":["INDICATIONS AND USAGE MALES Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. a. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchiectomy. b. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropic LHRH deficiency, or pituitary - hypothalamic injury from tumors, trauma or radiation. If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sex characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. Safety and efficacy of TESTOPEL ® (testosterone pellets) in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. c. Androgens may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An x-ray of the hand and wrist to determine bone age should be taken every 6 months to assess the effect of treatment on epiphyseal centers (see WARNINGS )."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Prior to initiating, TESTOPEL ® (testosterone pellets) confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. The suggested dosage for androgens varies depending on the age, and diagnosis of the individual patient. Dosage is adjusted according to the patient’s response and the appearance of adverse reactions. The dosage guideline for the testosterone pellets for replacement therapy in androgen-deficient males is 150mg to 450mg subcutaneously every 3 to 6 months. Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower doses initially, gradually increasing the dose as puberty progresses, with or without a decrease in maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. Dosages in delayed puberty generally are in the lower range of that listed above and, for a limited duration, for example 4 to 6 months. The number of pellets to be implanted depends upon the minimal daily requirements of testosterone propionate determined by a gradual reduction of the amount administered parenterally. The usual dosage is as follows: implant two 75mg pellets for each 25mg testosterone propionate required weekly. Thus when a patient requires injections of 75mg per week, it is usually necessary to implant 450mg (6 pellets). With injections of 50mg per week, implantation of 300mg (4 pellets) may suffice for approximately three months. With lower requirements by injection, correspondingly lower amounts may be implanted. It has been found that approximately one-third of the material is absorbed in the first month, one-fourth in the second month and one-sixth in the third month. Adequate effect of the pellets ordinarily continues for three to four months, sometimes as long as six months."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance TESTOPEL ® contains testosterone, a Schedule III controlled substance in the Controlled Substances Act. Abuse Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse of men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. Abuse-Related Adverse Reactions Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dependence Behaviors Associated with Addiction Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: Taking greater dosages than prescribed Continued drug use despite medical and social problems due to drug use Spending significant time to obtain the drug when supplies of the drug are interrupted Giving a higher priority to drug use than other obligations Having difficulty in discontinuing the drug despite desires and attempts to do so Experiencing withdrawal symptoms upon abrupt discontinuation of use Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented."],"spl_product_data_elements":["Testopel testosterone TESTOSTERONE TESTOSTERONE"],"package_label_principal_display_panel":["Principal Display Panel – Vial Label Vial label","Principal Display Panel – Box of 10 Vials 10ct carton","Principal Display Panel – Box of 100 Vials 100ct carton"]},"tags":[{"label":"Androgen","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Androgen receptor","category":"target"},{"label":"AR","category":"gene"},{"label":"SHBG","category":"gene"},{"label":"SERPINA6","category":"gene"},{"label":"G03BA03","category":"atc"},{"label":"Transdermal","category":"route"},{"label":"Topical","category":"route"},{"label":"Nasal","category":"route"},{"label":"Gel","category":"form"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Bilateral Anorchia","category":"indication"},{"label":"Bilateral orchidectomy","category":"indication"},{"label":"Chemotherapy-Induced Hypogonadism","category":"indication"},{"label":"Deficiency of testosterone biosynthesis","category":"indication"},{"label":"Delayed puberty","category":"indication"},{"label":"Hormone receptor positive malignant neoplasm of breast","category":"indication"},{"label":"Besins Hlthcare","category":"company"},{"label":"Approved 1970s","category":"decade"},{"label":"Androgens","category":"pharmacology"},{"label":"Hormones","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"3871 reports"},{"date":"","signal":"MYOCARDIAL INFARCTION","source":"FDA FAERS","actionTaken":"3712 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"2667 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"2541 reports"},{"date":"","signal":"CEREBROVASCULAR ACCIDENT","source":"FDA FAERS","actionTaken":"2383 reports"},{"date":"","signal":"DEEP VEIN THROMBOSIS","source":"FDA FAERS","actionTaken":"2383 reports"},{"date":"","signal":"BLOOD TESTOSTERONE DECREASED","source":"FDA FAERS","actionTaken":"2317 reports"},{"date":"","signal":"PULMONARY EMBOLISM","source":"FDA FAERS","actionTaken":"2228 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"2052 reports"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"1852 reports"}],"drugInteractions":[{"url":"/drug/warfarin","drug":"warfarin","action":"Avoid combination","effect":"May interact with Warfarin","source":"DrugCentral","drugSlug":"warfarin"}],"commonSideEffects":[{"effect":"Application Site Reactions","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Benign Prostatic Hyperplasia","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Blood Pressure Increased","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Headache","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Hematocrit/hemoglobin Increased","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Hot Flushes","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Insomnia","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Lacrimation Increased","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Mood Swings","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Smell Disorder","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Spontaneous Penile Erection","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Taste Disorder","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Blood Pressure Diastolic Decreased","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Gynecomastia","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Acne","drugRate":"reported","severity":"unknown"},{"effect":"Activated partial thromboplastin time prolonged","drugRate":"reported","severity":"unknown"},{"effect":"Appetite increased","drugRate":"reported","severity":"unknown"},{"effect":"Blood creatinine increased","drugRate":"reported","severity":"unknown"},{"effect":"Prothrombin time prolonged","drugRate":"reported","severity":"unknown"},{"effect":"Sensitive nipples","drugRate":"reported","severity":"unknown"},{"effect":"Vertigo","drugRate":"reported","severity":"unknown"},{"effect":"Coronary artery disease","drugRate":"reported","severity":"unknown"},{"effect":"Depression with suicidal ideation","drugRate":"reported","severity":"unknown"},{"effect":"Urinary tract infection/pneumonia","drugRate":"reported","severity":"unknown"},{"effect":"Hypertension","drugRate":"reported","severity":"unknown"}],"contraindications":["Arteriosclerotic vascular disease","Asthma","Benign prostatic hyperplasia","Body fluid retention","Breast Carcinoma in Males","Breast lump","Breastfeeding (mother)","Carcinoma of female breast","Cardiovascular event risk","Cerebrovascular accident","Chloasma","Chorea","Chronic heart failure","Chronic lung disease","Deep venous thrombosis","Dementia","Diabetes mellitus","Disease of liver","Disorder of coronary artery","Disorder of gallbladder","Edema","Endometrial carcinoma","Endometriosis","Epilepsy","Estrogen receptor positive tumor"],"specialPopulations":{"Pregnancy":"Testosterone is teratogenic and may cause fetal harm. Exposure of fetus to androgens may result in varying degrees of virilization.","Geriatric use":"There are insufficient long-term safety data in geriatric patients using Natesto to assess the potential risks of cardiovascular disease and prostate cancer. There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing Natesto to determine whether efficacy in those over 65 years of age differs from younger subjects.","Paediatric use":"Safety and efficacy of Natesto has not been established in pediatric patients less than 18 years of age. Improper use may result in acceleration of bone age and premature closure of epiphyses."}},"trials":[],"aliases":[],"company":"Besins Hlthcare","patents":[{"applNo":"N022309","source":"FDA Orange Book","status":"Active","expires":"Oct 12, 2026","useCode":"U-1103","territory":"US","drugProduct":false,"patentNumber":"8466137","drugSubstance":false},{"applNo":"N022309","source":"FDA Orange Book","status":"Active","expires":"Oct 12, 2026","useCode":"U-1103","territory":"US","drugProduct":false,"patentNumber":"8466138","drugSubstance":false},{"applNo":"N022309","source":"FDA Orange Book","status":"Active","expires":"Oct 12, 2026","useCode":"U-1103","territory":"US","drugProduct":false,"patentNumber":"8741881","drugSubstance":false},{"applNo":"N022309","source":"FDA Orange Book","status":"Active","expires":"Oct 12, 2026","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8754070","drugSubstance":false},{"applNo":"N022309","source":"FDA Orange Book","status":"Active","expires":"Oct 12, 2026","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8729057","drugSubstance":false},{"applNo":"N022309","source":"FDA Orange Book","status":"Active","expires":"Oct 12, 2026","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8759329","drugSubstance":false},{"applNo":"N022309","source":"FDA Orange Book","status":"Active","expires":"Oct 12, 2026","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8466136","drugSubstance":false},{"applNo":"N022309","source":"FDA Orange Book","status":"Active","expires":"Oct 12, 2026","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8486925","drugSubstance":false},{"type":"Formulation","number":"8785426","applicant":"UPSHER SMITH LABORATORIES LLC","territory":"US","tradeName":"VOGELXO","expiryDate":"2034-02-11"},{"type":"Formulation","number":"9662340","applicant":"UPSHER SMITH LABORATORIES LLC","territory":"US","tradeName":"VOGELXO","expiryDate":"2034-02-11"},{"type":"Method of Use","number":"8435944","applicant":"ELI LILLY AND CO","territory":"US","tradeName":"AXIRON","expiryDate":"2027-09-27"},{"type":"Formulation","number":"9295675","applicant":"UPSHER SMITH LABORATORIES LLC","territory":"US","tradeName":"VOGELXO","expiryDate":"2034-02-11"},{"type":"Method of Use","number":"9180194","applicant":"ELI LILLY AND CO","territory":"US","tradeName":"AXIRON","expiryDate":"2026-06-02"},{"type":"Formulation","number":"8807861","applicant":"ELI LILLY AND CO","territory":"US","tradeName":"AXIRON","expiryDate":"2027-02-26"},{"type":"Method of Use","number":"8993520","applicant":"ELI LILLY AND CO","territory":"US","tradeName":"AXIRON","expiryDate":"2026-06-02"},{"type":"Method of Use","number":"11744838","applicant":"ACERUS PHARMACEUTICALS CORP","territory":"US","tradeName":"NATESTO","expiryDate":"2034-03-17"},{"type":"Method of Use","number":"9289586","applicant":"ELI LILLY AND CO","territory":"US","tradeName":"AXIRON","expiryDate":"2027-02-26"},{"type":"Method of Use","number":"8419307","applicant":"ELI LILLY AND CO","territory":"US","tradeName":"AXIRON","expiryDate":"2027-02-26"},{"type":"Method of Use","number":"11090312","applicant":"ACERUS PHARMACEUTICALS CORP","territory":"US","tradeName":"NATESTO","expiryDate":"2034-03-17"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$1.3280/GM","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$485","description":"TESTOSTERONE 1% (25 MG/2.5 G) PK","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=TESTOSTERONE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:40:37.406708+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:40:37.406234+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:40:43.759684+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:40:21.830366+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TESTOSTERONE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:40:44.597162+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:40:20.420048+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:40:20.420098+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:41:06.451936+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:40:20.420112+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:40:46.206113+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Androgen Receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:40:45.262174+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200335/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:40:45.150595+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA080911","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:40:20.420121+00:00"}},"allNames":"androgel","offLabel":[],"synonyms":["testosterone","17beta-Testosterone"],"timeline":[{"date":"1972-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ACTIENT PHARMS to Besins Hlthcare"},{"date":"1972-07-13","type":"positive","source":"DrugCentral","milestone":"FDA approval (Actient Pharms)"},{"date":"1993-10-12","type":"positive","source":"FDA Orange Book","milestone":"Testoderm approved — 4MG/24HR"},{"date":"1997-05-02","type":"positive","source":"FDA Orange Book","milestone":"Androderm approved — 5MG/24HR"},{"date":"1997-12-18","type":"positive","source":"FDA Orange Book","milestone":"Testoderm Tts approved — 5MG/24HR"},{"date":"2000-02-28","type":"positive","source":"FDA Orange Book","milestone":"Androgel approved — 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"2002-10-31","type":"positive","source":"FDA Orange Book","milestone":"Testim approved — 50MG/5GM PACKET"},{"date":"2003-06-19","type":"positive","source":"FDA Orange Book","milestone":"Striant approved — 30MG"},{"date":"2010-11-23","type":"positive","source":"FDA Orange Book","milestone":"Axiron approved — 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"2010-12-29","type":"positive","source":"FDA Orange Book","milestone":"Fortesta approved — 10MG/0.5GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"2012-02-14","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Ani Pharms)"},{"date":"2013-01-31","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Perrigo Israel)"},{"date":"2014-05-28","type":"positive","source":"FDA Orange Book","milestone":"Natesto approved — 5.5MG/0.122GM ACTUATION"},{"date":"2014-06-04","type":"positive","source":"FDA Orange Book","milestone":"Vogelxo approved — 12.5MG/1.25GM ACTUATION"}],"aiSummary":"Androgel (testosterone) is a small molecule androgen that targets the androgen receptor. Originally developed by Actient Pharms and currently owned by Besins Healthcare, it was FDA-approved in 1972 for various indications including hypogonadism, delayed puberty, and hormone receptor-positive breast cancer. Androgel is available as a generic medication from multiple manufacturers. Key safety considerations include the potential for increased risk of cardiovascular events and prostate cancer. The commercial status of Androgel is generic, with 15 generic manufacturers available.","approvals":[{"date":"1972-07-13","orphan":false,"company":"ACTIENT PHARMS","regulator":"FDA"}],"brandName":"Androgel","ecosystem":[{"indication":"Bilateral Anorchia","otherDrugs":[{"name":"fluoxymesterone","slug":"fluoxymesterone","company":""},{"name":"methyltestosterone","slug":"methyltestosterone","company":"Valeant Pharm Intl"}],"globalPrevalence":null},{"indication":"Bilateral orchidectomy","otherDrugs":[],"globalPrevalence":null},{"indication":"Chemotherapy-Induced Hypogonadism","otherDrugs":[],"globalPrevalence":null},{"indication":"Deficiency of testosterone biosynthesis","otherDrugs":[{"name":"fluoxymesterone","slug":"fluoxymesterone","company":""},{"name":"methyltestosterone","slug":"methyltestosterone","company":"Valeant Pharm Intl"},{"name":"testosterone cypionate","slug":"testosterone-cypionate","company":"Watson Labs"},{"name":"testosterone enantate","slug":"testosterone-enantate","company":"Endo Pharms"}],"globalPrevalence":null},{"indication":"Delayed puberty","otherDrugs":[{"name":"fluoxymesterone","slug":"fluoxymesterone","company":""},{"name":"methyltestosterone","slug":"methyltestosterone","company":"Valeant Pharm Intl"},{"name":"testosterone cypionate","slug":"testosterone-cypionate","company":"Watson Labs"},{"name":"testosterone enantate","slug":"testosterone-enantate","company":"Endo Pharms"}],"globalPrevalence":null},{"indication":"Hormone receptor positive malignant neoplasm of breast","otherDrugs":[{"name":"abemaciclib","slug":"abemaciclib","company":"Eli Lilly And Co"},{"name":"anastrozole","slug":"anastrozole","company":"Astrazeneca"},{"name":"everolimus","slug":"everolimus","company":"Novartis"},{"name":"exemestane","slug":"exemestane","company":"Pharmacia And Upjohn"}],"globalPrevalence":null},{"indication":"Hypogonadotropic hypogonadism","otherDrugs":[{"name":"chorionic gonadotrophin","slug":"chorionic-gonadotrophin","company":"Ferring"},{"name":"testosterone undecanoate","slug":"testosterone-undecanoate","company":"Endo Pharms Inc"}],"globalPrevalence":null},{"indication":"Hypopituitarism","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"Androgen receptor","novelty":"Follow-on","targets":[{"gene":"AR","source":"DrugCentral","target":"Androgen receptor","protein":"Androgen receptor"},{"gene":"SHBG","source":"DrugCentral","target":"Sex hormone-binding globulin","protein":"Sex hormone-binding globulin"},{"gene":"SERPINA6","source":"DrugCentral","target":"Corticosteroid-binding globulin","protein":"Corticosteroid-binding globulin"},{"gene":"CYP19A1","source":"DrugCentral","target":"Aromatase","protein":"Aromatase"},{"gene":"SIGMAR1","source":"DrugCentral","target":"Sigma non-opioid intracellular receptor 1","protein":"Sigma non-opioid intracellular receptor 1"},{"gene":"NR3C1","source":"DrugCentral","target":"Glucocorticoid receptor","protein":"Glucocorticoid receptor"},{"gene":"CYP51A1","source":"DrugCentral","target":"Lanosterol 14-alpha demethylase","protein":"Lanosterol 14-alpha demethylase"},{"gene":"SNCA","source":"DrugCentral","target":"Alpha-synuclein","protein":"Alpha-synuclein"}],"moaClass":"Androgen Receptor Agonists","modality":"Small Molecule","drugClass":"Androgen [EPC]","explanation":"","oneSentence":"","technicalDetail":"Androgel is a non-steroidal, small molecule androgen that competitively binds to androgen receptors, activating downstream signaling pathways and mimicking the effects of endogenous testosterone."},"commercial":{"launchDate":"1972","_launchSource":"DrugCentral (FDA 1972-07-13, ACTIENT PHARMS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2607","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=TESTOSTERONE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TESTOSTERONE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T15:51:40.253425","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T00:41:06.720772+00:00","fieldsConflicting":15,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"fluoxymesterone","drugSlug":"fluoxymesterone","fdaApproval":"1956-10-15","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"methyltestosterone","drugSlug":"methyltestosterone","fdaApproval":"1973-12-03","genericCount":20,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"testosterone","indications":{"approved":[{"id":"testosterone-primary-hypogonadism","name":"Primary Hypogonadism","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Males with primary hypogonadism","pivotalTrial":null,"restrictions":[],"patientPopulation":"Males with primary hypogonadism","diagnosticRequired":null,"brandNameForIndication":"Androgel"},{"id":"testosterone-hypogonadotropic-hypogonadism","name":"Hypogonadotropic Hypogonadism","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Males with hypogonadotropic hypogonadism","pivotalTrial":null,"restrictions":[],"patientPopulation":"Males with hypogonadotropic hypogonadism","diagnosticRequired":null,"brandNameForIndication":"Androgel"},{"id":"testosterone-stimulation-of-puberty","name":"Stimulation of Puberty","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Males with clearly delayed puberty","pivotalTrial":null,"restrictions":[],"patientPopulation":"Males with clearly delayed puberty","diagnosticRequired":null,"brandNameForIndication":"Androgel"}],"offLabel":[{"name":"Noonan's syndrome","source":"DrugCentral","drugName":"TESTOSTERONE","evidenceCount":29,"evidenceLevel":"moderate"}],"pipeline":[]},"currentOwner":"Besins Hlthcare","drugCategory":"established","labelChanges":[],"relatedDrugs":[{"drugId":"fluoxymesterone","brandName":"fluoxymesterone","genericName":"fluoxymesterone","approvalYear":"1956","relationship":"same-class"},{"drugId":"methyltestosterone","brandName":"methyltestosterone","genericName":"methyltestosterone","approvalYear":"1973","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07500766","phase":"PHASE2","title":"Clinical Evaluation of Subcutaneous Testosterone Implants in Men With Symptomatic Hypogonadism","status":"NOT_YET_RECRUITING","sponsor":"University of Sao Paulo","startDate":"2026-03","conditions":["Male Hypogonadism","Testosterone Deficiency","Testosterone Replacement Therapy","Testosterone"],"enrollment":30,"completionDate":"2027-04"},{"nctId":"NCT05893069","phase":"PHASE4","title":"Oxandrolone Multiligament Knee","status":"SUSPENDED","sponsor":"George F. Hatch","startDate":"2023-07-01","conditions":["Ligament Tear Knee"],"enrollment":60,"completionDate":"2027-12-31"},{"nctId":"NCT06610968","phase":"NA","title":"Acute Vitamin D Supplementation on Testosterone in Females","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Southern California","startDate":"2025-07-01","conditions":["Female Hormone Profile"],"enrollment":20,"completionDate":"2026-09-30"},{"nctId":"NCT06096870","phase":"PHASE2","title":"Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-04-22","conditions":["Prostate Cancer","Recurrent Prostate Cancer","PET Positive"],"enrollment":65,"completionDate":"2029-12-31"},{"nctId":"NCT05051293","phase":"","title":"Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension","status":"WITHDRAWN","sponsor":"Methodist Health System","startDate":"2021-08-22","conditions":["Hypotension","Cirrhosis"],"enrollment":0,"completionDate":"2024-08-17"},{"nctId":"NCT00588185","phase":"NA","title":"[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2003-02","conditions":["Prostate Cancer"],"enrollment":300,"completionDate":"2027-02"},{"nctId":"NCT07481942","phase":"","title":"Body Composition Assessment in Transgender Population.","status":"COMPLETED","sponsor":"Celia Bañuls","startDate":"2017-01-01","conditions":["Transgender"],"enrollment":70,"completionDate":"2025-10-31"},{"nctId":"NCT07476222","phase":"","title":"PREDICTORS OF TESTOSTERONE DECLINE IN MIDDLE-AGED MEN","status":"NOT_YET_RECRUITING","sponsor":"Andijan State Medical Institute","startDate":"2026-04-01","conditions":["Testosterone Deficiency","Androgen Deficiency","Male Hypogonadism"],"enrollment":800,"completionDate":"2027-12-31"},{"nctId":"NCT03767244","phase":"PHASE3","title":"A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2019-06-11","conditions":["Prostatic Neoplasms"],"enrollment":2517,"completionDate":"2028-10-13"},{"nctId":"NCT04675788","phase":"PHASE4","title":"Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening","status":"COMPLETED","sponsor":"Indiana University","startDate":"2021-09-02","conditions":["Long QT Syndrome","Abnormalities, Drug-Induced"],"enrollment":73,"completionDate":"2025-04-16"},{"nctId":"NCT04798469","phase":"PHASE2","title":"Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism","status":"RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2022-01-10","conditions":["Opioid Use","Pain","Hypogonadism, Male"],"enrollment":150,"completionDate":"2027-12-30"},{"nctId":"NCT06998238","phase":"NA","title":"Evaluating the Influence of Diet-induced Weight Loss on Fat (Adipose) Tissue's Insulin Sensitivity and Testosterone Synthesis in Women With Overweight or Obesity, Insulin Resistance, and Hyperandrogenemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Missouri-Columbia","startDate":"2024-01-07","conditions":["Overweight and Obesity","Hyperandrogenemia","Insulin Resistance"],"enrollment":8,"completionDate":"2026-04-01"},{"nctId":"NCT07476001","phase":"PHASE2","title":"Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC","status":"RECRUITING","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2026-03","conditions":["Metastatic Castration-resistant Prostate Cancer"],"enrollment":12,"completionDate":"2027-09"},{"nctId":"NCT05935761","phase":"PHASE2","title":"Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial","status":"NOT_YET_RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2026-06-01","conditions":["Chronic Low Back Pain"],"enrollment":108,"completionDate":"2029-12-31"},{"nctId":"NCT06075953","phase":"PHASE2","title":"DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment","status":"RECRUITING","sponsor":"QuantumLeap Healthcare Collaborative","startDate":"2024-02-17","conditions":["Ductal Carcinoma in Situ"],"enrollment":400,"completionDate":"2033-11"},{"nctId":"NCT07460960","phase":"PHASE2","title":"TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men","status":"RECRUITING","sponsor":"Lomonosov Moscow State University Medical Research and Educational Center","startDate":"2026-03-05","conditions":["Erectile Dysfunction Due to Arterial Disease","Atheroscleroses","Erectile Disfunction","Endothelial Dysfunction","Androgen Profile","Testosterone"],"enrollment":150,"completionDate":"2027-12"},{"nctId":"NCT07335796","phase":"PHASE2","title":"A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2026-01-09","conditions":["Prostate Cancer"],"enrollment":30,"completionDate":"2030-01-09"},{"nctId":"NCT07463508","phase":"NA","title":"Evaluation of Bile Acid Concentrations and Their Signaling as Markers of Testicular Tumorigenesis and Germ Cell Tumor Chemosensitivity","status":"RECRUITING","sponsor":"University Hospital, Clermont-Ferrand","startDate":"2026-01-01","conditions":["Testicular Germ Cell Cancer"],"enrollment":20,"completionDate":"2029-01-01"},{"nctId":"NCT05787470","phase":"","title":"State of Hormones Impact Nociceptive Expression","status":"RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2023-03-01","conditions":["Pain","Gender Identity"],"enrollment":120,"completionDate":"2026-07-31"},{"nctId":"NCT05526248","phase":"PHASE2","title":"A Study Called ARAMON to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide","status":"COMPLETED","sponsor":"Bayer","startDate":"2022-12-19","conditions":["Biochemically Recurrent Prostate Cancer"],"enrollment":28,"completionDate":"2024-12-04"},{"nctId":"NCT07142551","phase":"PHASE2","title":"Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response","status":"RECRUITING","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2026-03-09","conditions":["Metastatic Castration-resistant Prostate Cancer"],"enrollment":60,"completionDate":"2034-06-01"},{"nctId":"NCT05964920","phase":"PHASE2,PHASE3","title":"Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?","status":"COMPLETED","sponsor":"Norwegian School of Sport Sciences","startDate":"2024-09-01","conditions":["Healthy Aging","Age-Related Sarcopenia","Testosterone Deficiency"],"enrollment":45,"completionDate":"2026-02-06"},{"nctId":"NCT05726292","phase":"PHASE2","title":"A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer","status":"RECRUITING","sponsor":"University of Chicago","startDate":"2025-01-06","conditions":["Prostate Cancer","Prostate Adenocarcinoma"],"enrollment":90,"completionDate":"2028-04-01"},{"nctId":"NCT07254429","phase":"PHASE2","title":"COMPASS - COpenhagen MenoPAuSe Study","status":"RECRUITING","sponsor":"Martin Blomberg Jensen","startDate":"2025-10-02","conditions":["Menopausal Osteoporosis","Bone Markers"],"enrollment":192,"completionDate":"2028-05"},{"nctId":"NCT04104893","phase":"PHASE2","title":"A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation","status":"ACTIVE_NOT_RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2020-02-20","conditions":["Metastatic Castration Resistant Prostate Cancer"],"enrollment":40,"completionDate":"2026-12-31"},{"nctId":"NCT07179952","phase":"PHASE2","title":"Efficacy and Safety of Slow Release Dehydroepiandrosterone (DHEA )","status":"NOT_YET_RECRUITING","sponsor":"Indiana University","startDate":"2027-01-01","conditions":["Asthma"],"enrollment":30,"completionDate":"2028-09-30"},{"nctId":"NCT05617885","phase":"PHASE1","title":"Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Praful Ravi, MB BCHir, MRCP","startDate":"2023-08-09","conditions":["Metastatic Prostate Cancer","Non-metastatic Prostate Cancer","Prostate Cancer"],"enrollment":9,"completionDate":"2026-06-01"},{"nctId":"NCT05951452","phase":"","title":"The Developmental Origins of Endometriosis","status":"RECRUITING","sponsor":"University Hospital, Montpellier","startDate":"2024-01-08","conditions":["Endometriosis"],"enrollment":40,"completionDate":"2026-10-08"},{"nctId":"NCT06855277","phase":"PHASE3","title":"Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2025-07-01","conditions":["Prostate Cancer"],"enrollment":940,"completionDate":"2032-11-04"},{"nctId":"NCT07278362","phase":"PHASE4","title":"Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance","status":"NOT_YET_RECRUITING","sponsor":"University of Miami","startDate":"2026-05-31","conditions":["Prostate Cancer","Hypogonadism, Male"],"enrollment":35,"completionDate":"2032-05-31"},{"nctId":"NCT04743466","phase":"","title":"Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2020-02-13","conditions":["Anxiety Disorder","Depression","Genetic Disorder","Hematopoietic and Lymphoid Cell Neoplasm","Malignant Solid Neoplasm"],"enrollment":1,"completionDate":"2028-11-30"},{"nctId":"NCT06305598","phase":"PHASE1","title":"Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer","status":"RECRUITING","sponsor":"Roswell Park Cancer Institute","startDate":"2024-12-19","conditions":["Castration-Resistant Prostate Carcinoma","Metastatic Prostate Carcinoma","Stage IVB Prostate Cancer AJCC v8"],"enrollment":14,"completionDate":"2027-12-15"},{"nctId":"NCT06689085","phase":"PHASE3","title":"52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism","status":"RECRUITING","sponsor":"Halozyme Therapeutics","startDate":"2025-03-07","conditions":["Hypogonadism, Male"],"enrollment":100,"completionDate":"2030-03"},{"nctId":"NCT05894954","phase":"PHASE3","title":"Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment","status":"COMPLETED","sponsor":"Alzheimer's Prevention and Reversal Project, Inc.","startDate":"2023-07-31","conditions":["Mild Cognitive Impairment","Dementia, Mild"],"enrollment":73,"completionDate":"2026-02-09"},{"nctId":"NCT07408440","phase":"NA","title":"Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause","status":"NOT_YET_RECRUITING","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2026-04-01","conditions":["Menopause","Sexual Dysfunction","Libido Disorder","Testosterone Deficiency"],"enrollment":150,"completionDate":"2028-03-30"},{"nctId":"NCT04316650","phase":"NA","title":"Study of Maintenance of the Efficiency and Adverse Effects of Pharmacological Treatments in Sex Offenders With Paraphilia","status":"WITHDRAWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2023-06","conditions":["Paraphilia"],"enrollment":0,"completionDate":"2027-10"},{"nctId":"NCT07143279","phase":"EARLY_PHASE1","title":"Testosterone Supplementation in Patients in Best Supportive Care: Impact on Quality of Life","status":"RECRUITING","sponsor":"Jules Bordet Institute","startDate":"2026-02-11","conditions":["Hypotestosteronism","Palliative Care"],"enrollment":20,"completionDate":"2027-11"},{"nctId":"NCT04558866","phase":"PHASE2","title":"Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Latin American Cooperative Oncology Group","startDate":"2021-06-09","conditions":["Prostate Cancer"],"enrollment":51,"completionDate":"2026-06"},{"nctId":"NCT07407647","phase":"PHASE2","title":"Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer","status":"RECRUITING","sponsor":"Ohio State University Comprehensive Cancer Center","startDate":"2026-03-01","conditions":["Anal Carcinoma","Cervical Carcinoma","Malignant Female Reproductive System Neoplasm","Rectal Carcinoma","Vaginal Carcinoma","Vulvar Carcinoma"],"enrollment":25,"completionDate":"2026-12-31"},{"nctId":"NCT04731376","phase":"PHASE1","title":"Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone","status":"ACTIVE_NOT_RECRUITING","sponsor":"Emory University","startDate":"2021-01-25","conditions":["Hypogonadism","Malignant Urinary System Neoplasm","Urinary System Disorder","Urinary System Neoplasm"],"enrollment":56,"completionDate":"2026-12-31"},{"nctId":"NCT07212712","phase":"NA","title":"The Role of Estrogen and Testosterone in Determining Brain Blood Flow and Metabolic Regulation in Humans","status":"NOT_YET_RECRUITING","sponsor":"University of British Columbia","startDate":"2026-04-01","conditions":["Cerebral Blood Flow","Cerebral Blood Flow Regulation","Sex Differences","Exercise","Vascular"],"enrollment":50,"completionDate":"2027-12-31"},{"nctId":"NCT06733350","phase":"PHASE4","title":"Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance","status":"SUSPENDED","sponsor":"Roswell Park Cancer Institute","startDate":"2025-01-15","conditions":["Localized Prostate Carcinoma","Stage I Prostate Cancer AJCC v8","Stage II Prostate Cancer AJCC v8","Stage III Prostate Cancer AJCC v8"],"enrollment":600,"completionDate":"2029-01-15"},{"nctId":"NCT02994602","phase":"PHASE1","title":"Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males","status":"COMPLETED","sponsor":"Kimberly Myer","startDate":"2017-01","conditions":["Healthy Men","Male Contraception","Healthy Women","Product Transference"],"enrollment":26,"completionDate":"2017-10"},{"nctId":"NCT07397702","phase":"NA","title":"Effects of HIIT and MICT Training on Cardiorespiratory Fitness, Testosterone/Cortisol Ratio, and Mental Health in Young Adults","status":"NOT_YET_RECRUITING","sponsor":"Universidad de Colima","startDate":"2026-05-25","conditions":["Exercise"],"enrollment":76,"completionDate":"2026-08-07"},{"nctId":"NCT07393867","phase":"PHASE2","title":"Androgen-responsive POSLUMA-guided Intra-prostatic Boost","status":"NOT_YET_RECRUITING","sponsor":"Martin T. King, MD, PhD","startDate":"2026-03","conditions":["Intermediate Risk Prostate Cancer","High Risk Prostate Cancer","Prostate Cancer"],"enrollment":23,"completionDate":"2027-12"},{"nctId":"NCT04455750","phase":"PHASE3","title":"A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2021-10-14","conditions":["Castration-Resistant Prostate Carcinoma","Metastatic Prostate Adenocarcinoma","Stage IV Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","Stage IVB Prostate Cancer AJCC v8"],"enrollment":61,"completionDate":"2027-09"},{"nctId":"NCT04729114","phase":"PHASE1","title":"A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer","status":"RECRUITING","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2021-06-14","conditions":["Prostate Cancer","Metastatic Castration Resistant Prostate Cancer","Metastatic Castration-sensitive Prostate Cancer"],"enrollment":174,"completionDate":"2029-05-31"},{"nctId":"NCT06720597","phase":"NA","title":"EndoPAT Device for Endothelial Dysfunction in ED","status":"RECRUITING","sponsor":"University of California, Irvine","startDate":"2025-08-13","conditions":["Erectile Dysfunction","Hypogonadism, Male","Endothelial Dysfunction"],"enrollment":120,"completionDate":"2027-01"},{"nctId":"NCT07138222","phase":"","title":"IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma","status":"RECRUITING","sponsor":"Peter MacCallum Cancer Centre, Australia","startDate":"2025-09-11","conditions":["Melanoma (Skin Cancer)"],"enrollment":80,"completionDate":"2027-12"},{"nctId":"NCT05498272","phase":"PHASE2","title":"Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations","status":"RECRUITING","sponsor":"Rana McKay, MD","startDate":"2023-02-01","conditions":["Prostate Cancer","BRCA1 Mutation","BRCA2 Mutation","Prostatic Adenocarcinoma","High-Risk Cancer"],"enrollment":32,"completionDate":"2026-12"},{"nctId":"NCT07092527","phase":"PHASE4","title":"Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version","status":"RECRUITING","sponsor":"University of California, San Diego","startDate":"2025-12-05","conditions":["Transgenderism","Reproductive Issues"],"enrollment":80,"completionDate":"2028-11-30"},{"nctId":"NCT07339436","phase":"NA","title":"Lower Body Plyometric Training Effects on Upper Body in Basketball Players","status":"COMPLETED","sponsor":"Birjand University of Medical Sciences","startDate":"2024-09-20","conditions":["Basketball Performance"],"enrollment":50,"completionDate":"2025-03-20"},{"nctId":"NCT06039371","phase":"PHASE2","title":"Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study","status":"RECRUITING","sponsor":"University of Washington","startDate":"2024-05-21","conditions":["Castration-Resistant Prostate Carcinoma","Metastatic Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8"],"enrollment":69,"completionDate":"2027-12-31"},{"nctId":"NCT06072677","phase":"NA","title":"Adolescent Mood During Puberty and Testosterone","status":"RECRUITING","sponsor":"University of North Carolina, Chapel Hill","startDate":"2023-08-24","conditions":["Adolescent Depression"],"enrollment":60,"completionDate":"2027-12"},{"nctId":"NCT06059118","phase":"PHASE2","title":"Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer","status":"RECRUITING","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2023-10-04","conditions":["Prostate Cancer"],"enrollment":50,"completionDate":"2029-11-30"},{"nctId":"NCT06130449","phase":"EARLY_PHASE1","title":"Testosterone and Neural Function","status":"RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2024-04-01","conditions":["Spinal Cord Injury"],"enrollment":15,"completionDate":"2026-09-30"},{"nctId":"NCT07328542","phase":"PHASE4","title":"Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men","status":"NOT_YET_RECRUITING","sponsor":"Azurity Pharmaceuticals","startDate":"2026-02","conditions":["Hypogonadism, Male"],"enrollment":144,"completionDate":"2027-08"},{"nctId":"NCT07329998","phase":"NA","title":"The Aim of the Study is to Check Whether Follicular Fluid Evaluation Using a Spectrophotometer Can Differentiate High Quality Oocytes From Low Quality Oocytes. Oocyte Quality Will be Defined Using GDF9, BMP15 and Oocyte Morphology.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hillel Yaffe Medical Center","startDate":"2024-09-22","conditions":["Oocyte Quality Assessment Using Spectrophotometer"],"enrollment":200,"completionDate":"2026-11-01"},{"nctId":"NCT07328789","phase":"","title":"Factors Influencing Cardiac Rehabilitation Success","status":"NOT_YET_RECRUITING","sponsor":"Pomeranian Medical University Szczecin","startDate":"2026-01-03","conditions":["Rehabilitation"],"enrollment":150,"completionDate":"2029-07-01"},{"nctId":"NCT04439370","phase":"","title":"Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women","status":"RECRUITING","sponsor":"University of Minnesota","startDate":"2019-10-01","conditions":["Hypertension","Menopause, Premature","Menopause","Blood Pressure"],"enrollment":160,"completionDate":"2026-12-30"},{"nctId":"NCT07323329","phase":"PHASE2,PHASE3","title":"Growth Hormone and Dehydroepiandrosterone Role in Vitro Fertilization","status":"RECRUITING","sponsor":"Beni-Suef University","startDate":"2025-10-10","conditions":["Infertility","Infertility (IVF Patients)"],"enrollment":165,"completionDate":"2026-11-12"},{"nctId":"NCT06866119","phase":"","title":"Effects of Estrogen on Heart Health in Women With Primary Ovarian Insufficiency","status":"NOT_YET_RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2026-03-01","conditions":["Primary Ovarian Insufficiency","Premature Menopause","Metabolic Complications","Endothelial Function (FMD)","Estrogen Replacement Therapy"],"enrollment":45,"completionDate":"2026-06"},{"nctId":"NCT07302451","phase":"PHASE2","title":"REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute, Naples","startDate":"2025-12-01","conditions":["Prostate Cancer (Adenocarcinoma)"],"enrollment":50,"completionDate":"2030-12-31"},{"nctId":"NCT06084338","phase":"PHASE2","title":"Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc","status":"RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2023-12-14","conditions":["Prostate Cancer"],"enrollment":60,"completionDate":"2028-12-31"},{"nctId":"NCT06343870","phase":"PHASE3","title":"Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)","status":"RECRUITING","sponsor":"University of Sao Paulo General Hospital","startDate":"2025-12-18","conditions":["Menopause","Testosterone Deficiency","Estrogen Deficiency"],"enrollment":140,"completionDate":"2027-04-30"},{"nctId":"NCT04895306","phase":"PHASE2","title":"Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2022-11-15","conditions":["Pain","Opioid Use","Androgen Deficiency","Back Pain"],"enrollment":40,"completionDate":"2026-06-30"},{"nctId":"NCT07299292","phase":"PHASE2","title":"Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)","status":"RECRUITING","sponsor":"SMED Clinical Research","startDate":"2025-12-01","conditions":["Prostate Cancer (Diagnosis)"],"enrollment":60,"completionDate":"2027-03-30"},{"nctId":"NCT03887936","phase":"PHASE4","title":"Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism","status":"ACTIVE_NOT_RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2019-10-01","conditions":["Type 2 Diabetes Mellitus","Hypogonadism"],"enrollment":92,"completionDate":"2026-06-30"},{"nctId":"NCT05241860","phase":"PHASE2","title":"Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2022-11-21","conditions":["Castration-Sensitive Prostate Carcinoma","Metastatic Prostate Carcinoma","Stage IV Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","Stage IVB Prostate Cancer AJCC v8"],"enrollment":79,"completionDate":"2033-09-01"},{"nctId":"NCT07287800","phase":"PHASE1,PHASE2","title":"TRT as an Adjunctive ERAS Therapy in ESRD Patients Undergoing Kidney Transplantation","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of California, Los Angeles","startDate":"2025-07-01","conditions":["Hypogonadism, Male","End Stage Renal Disease (ESRD)","Kidney Transplant"],"enrollment":50,"completionDate":"2027-06"},{"nctId":"NCT04025372","phase":"PHASE2","title":"INTREPId (INTermediate Risk Erection PreservatIon Trial)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2020-06-01","conditions":["Prostate Cancer"],"enrollment":234,"completionDate":"2028-03-01"},{"nctId":"NCT05555680","phase":"","title":"Effect of Hyperandrogenism on IVF Outcomes in PCOS Patients","status":"TERMINATED","sponsor":"Clinique Ovo","startDate":"2022-01-21","conditions":["PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries"],"enrollment":32,"completionDate":"2025-01-29"},{"nctId":"NCT04838249","phase":"","title":"Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System","status":"RECRUITING","sponsor":"University of Leipzig","startDate":"2021-05-05","conditions":["Transsexualism","Transgenderism","Adiposity","Eating Behavior","Arterial Stiffness","Microangiopathy"],"enrollment":80,"completionDate":"2026-05"},{"nctId":"NCT05623397","phase":"","title":"A Deep Learning Method to Evaluate QT on Ribociclib","status":"COMPLETED","sponsor":"CMC Ambroise Paré","startDate":"2023-07-28","conditions":["Breast Cancer","Ribociclib"],"enrollment":70,"completionDate":"2025-10-08"},{"nctId":"NCT03511196","phase":"EARLY_PHASE1","title":"Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2018-09-17","conditions":["Prostate Cancer","Stage IV Prostate Cancer","Advanced Prostate Cancer","Adenocarcinoma of the Prostate"],"enrollment":17,"completionDate":"2026-09"},{"nctId":"NCT05914324","phase":"NA","title":"Outpatient Pediatric Pulse Oximeters in Africa","status":"RECRUITING","sponsor":"Johns Hopkins University","startDate":"2024-11-04","conditions":["Child","Infant","Respiratory Tract Infections","Hypoxia"],"enrollment":1200,"completionDate":"2026-12-31"},{"nctId":"NCT07260825","phase":"PHASE2,PHASE3","title":"Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial","status":"NOT_YET_RECRUITING","sponsor":"TriHealth Inc.","startDate":"2025-12","conditions":["Vulvodynia","Dyspareunia","Lichen Sclerosus of Vulva"],"enrollment":44,"completionDate":"2026-08"},{"nctId":"NCT06594926","phase":"PHASE2","title":"Working Out M0 Bipolar Androgen Therapy","status":"RECRUITING","sponsor":"Australian and New Zealand Urogenital and Prostate Cancer Trials Group","startDate":"2024-08-14","conditions":["Prostate Cancer"],"enrollment":69,"completionDate":"2028-12-31"},{"nctId":"NCT01961843","phase":"NA","title":"Abiraterone Acetate for Castrate Resistant Prostate Cancer","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2014-01-14","conditions":["Prostate Cancer"],"enrollment":40,"completionDate":"2024-05-31"},{"nctId":"NCT07227740","phase":"","title":"Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury","status":"RECRUITING","sponsor":"Craig Hospital","startDate":"2025-07-15","conditions":["Spinal Cord Injuries","Endothelial Dysfunction","Testosterone Deficiency"],"enrollment":48,"completionDate":"2028-07-14"},{"nctId":"NCT05669664","phase":"PHASE2","title":"Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2023-07-20","conditions":["Locally Advanced Salivary Gland Carcinoma","Metastatic Salivary Gland Carcinoma","Recurrent Salivary Gland Carcinoma","Unresectable Salivary Gland Carcinoma"],"enrollment":21,"completionDate":"2027-04-11"},{"nctId":"NCT03734653","phase":"EARLY_PHASE1","title":"Testosterone Therapy in Castration Resistant Prostate Cancer","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2019-01-18","conditions":["Prostate Cancer","Castration-Resistant Prostate Cancer"],"enrollment":30,"completionDate":"2025-09-30"},{"nctId":"NCT03648385","phase":"PHASE2","title":"Effects of DHEA in Pulmonary Hypertension","status":"COMPLETED","sponsor":"Rhode Island Hospital","startDate":"2019-01-09","conditions":["Pulmonary Arterial Hypertension"],"enrollment":26,"completionDate":"2024-12-30"},{"nctId":"NCT04807894","phase":"PHASE4","title":"Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo","status":"RECRUITING","sponsor":"Maimonides Medical Center","startDate":"2020-11-01","conditions":["Recurrent Urinary Tract Infection","Vaginal Atrophy","Postmenopausal Disorder"],"enrollment":100,"completionDate":"2026-12-31"},{"nctId":"NCT06100705","phase":"PHASE2","title":"Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC","status":"RECRUITING","sponsor":"Yale University","startDate":"2023-12-20","conditions":["Metastatic Castration-resistant Prostate Cancer"],"enrollment":26,"completionDate":"2028-03"},{"nctId":"NCT04812912","phase":"","title":"Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2021-03-18","conditions":["Colorectal Cancer","Colorectal Neoplasms","Colorectal Carcinoma"],"enrollment":120,"completionDate":"2026-03-18"},{"nctId":"NCT05738213","phase":"NA","title":"Puberty, Sex Hormones and Pain Sensitivity in Adolescents With Migraine","status":"ACTIVE_NOT_RECRUITING","sponsor":"Washington University School of Medicine","startDate":"2023-01-10","conditions":["Migraine"],"enrollment":100,"completionDate":"2028-01-01"},{"nctId":"NCT03345576","phase":"PHASE2","title":"Testosterone and Long Pulse Stimulation After SCI","status":"COMPLETED","sponsor":"VA Office of Research and Development","startDate":"2018-07-01","conditions":["Spinal Cord Injury"],"enrollment":12,"completionDate":"2023-11-30"},{"nctId":"NCT03228732","phase":"EARLY_PHASE1","title":"The Effects of Fluoxetine and/or DHEA","status":"RECRUITING","sponsor":"University of Maryland, Baltimore","startDate":"2017-12-19","conditions":["Type 1 Diabetes Mellitus"],"enrollment":60,"completionDate":"2026-12-15"},{"nctId":"NCT04977765","phase":"","title":"Cardiometabolic Health in Transgender Males","status":"ACTIVE_NOT_RECRUITING","sponsor":"Medical College of Wisconsin","startDate":"2021-09-30","conditions":["Transgender","Transgenderism"],"enrollment":90,"completionDate":"2027-08-01"},{"nctId":"NCT04265053","phase":"EARLY_PHASE1","title":"Human Cerebral Blood Flow Regulation","status":"COMPLETED","sponsor":"University of Wisconsin, Madison","startDate":"2021-04-12","conditions":["Cerebral Arterial Diseases"],"enrollment":110,"completionDate":"2025-05-31"},{"nctId":"NCT06245681","phase":"","title":"Effects of Cross-sex Hormone Treatment on Cardiac Function, Myocardial and Hepatic Fat Content","status":"RECRUITING","sponsor":"Medical University of Vienna","startDate":"2017-10-20","conditions":["Gender Dysphoria"],"enrollment":40,"completionDate":"2028-10-20"},{"nctId":"NCT06824818","phase":"NA","title":"Study to Assess the Feasibility of Stopping Prostate Cancer Treatment Early in Elderly Patients","status":"RECRUITING","sponsor":"University of Chicago","startDate":"2026-06","conditions":["Elderly","Prostate Cancer"],"enrollment":155,"completionDate":"2027-06"},{"nctId":"NCT03516812","phase":"PHASE2","title":"Testosterone and Olaparib in Treating Patients With Castration-Resistant Prostate Cancer","status":"COMPLETED","sponsor":"University of Washington","startDate":"2018-08-29","conditions":["Castration-Resistant Prostate Carcinoma","Prostate Adenocarcinoma"],"enrollment":36,"completionDate":"2024-04-12"},{"nctId":"NCT06291675","phase":"","title":"Gender-Affirming Hormone Therapy and Its Impact on Myocardial Mass and Cardiac Function, Heart, Liver and Pancreatic Fat Content","status":"RECRUITING","sponsor":"Medical University of Vienna","startDate":"2023-03-03","conditions":["Gender Dysphoria","Hormone Therapy Induced Morphologic Change"],"enrollment":50,"completionDate":"2033-03-03"},{"nctId":"NCT07187947","phase":"","title":"Cardiovascular Health of Transgender Individuals During the Gender-affirming Pathway","status":"RECRUITING","sponsor":"IRCCS Azienda Ospedaliero-Universitaria di Bologna","startDate":"2025-07-18","conditions":["Gender Incongruence","Cardiovascular (CV) Risk","Cardiovascular Disease Risk Factor","Cardiovascular Disease Acute","Cardiovascular Health Status","Cardiovascular Disease (CVD)","Cardiovascular Disease Prevention"],"enrollment":500,"completionDate":"2035-12-31"},{"nctId":"NCT03716739","phase":"PHASE2","title":"Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency","status":"COMPLETED","sponsor":"Dana-Farber Cancer Institute","startDate":"2019-03-19","conditions":["Prostate Cancer"],"enrollment":136,"completionDate":"2025-07-16"},{"nctId":"NCT02703220","phase":"PHASE4","title":"Sleep Apnea in Elderly","status":"RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2015-07-03","conditions":["Sleep Apnea","Elderly Adults"],"enrollment":100,"completionDate":"2026-07-31"},{"nctId":"NCT05081193","phase":"PHASE2","title":"Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer","status":"COMPLETED","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2022-03-07","conditions":["Prostate Cancer","Castration-resistant Prostate Cancer","Metastatic Castration-resistant Prostate Cancer"],"enrollment":15,"completionDate":"2025-08-04"},{"nctId":"NCT03576001","phase":"PHASE2","title":"Multimodality Intervention for Function and Metabolism in SCI","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2019-08-23","conditions":["Spinal Cord Injuries"],"enrollment":84,"completionDate":"2025-03-30"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Subcutaneous","formulation":"Gel","formulations":[{"form":"GEL","route":"NASAL","productName":"Natesto"},{"form":"GEL","route":"TOPICAL","productName":"Testosterone"},{"form":"GEL","route":"TOPICAL","productName":"testosterone"},{"form":"GEL","route":"TOPICAL","productName":"Testim"},{"form":"GEL","route":"TOPICAL","productName":"Testosterone"},{"form":"GEL","route":"TOPICAL","productName":"Vogelxo"},{"form":"GEL","route":"TOPICAL","productName":"Testosterone"},{"form":"GEL","route":"TRANSDERMAL","productName":"TESTOSTERONE"},{"form":"GEL","route":"TRANSDERMAL","productName":"Testosterone"},{"form":"GEL","route":"TRANSDERMAL","productName":"Testosterone Gel, 1%"},{"form":"GEL","route":"TRANSDERMAL","productName":"AndroGel"},{"form":"GEL","route":"TRANSDERMAL","productName":"Androgel"},{"form":"GEL","route":"TRANSDERMAL","productName":"Testim"},{"form":"GEL","route":"TRANSDERMAL","productName":"Testosterone"},{"form":"GEL, METERED","route":"NASAL","productName":"Natesto\nnasal gel"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000145872","MMSL":"2966","NDDF":"001245","UNII":"3XMK78S47O","VUID":"4017484","CHEBI":"CHEBI:17347","VANDF":"4017484","INN_ID":"1900","RXNORM":"10379","UMLSCUI":"C0039601","chemblId":"CHEMBL1200335","ChEMBL_ID":"CHEMBL386630","KEGG_DRUG":"D00075","DRUGBANK_ID":"DB00624","PDB_CHEM_ID":" TES","PUBCHEM_CID":"6013","SNOMEDCT_US":"109033004","IUPHAR_LIGAND_ID":"2858","MESH_DESCRIPTOR_UI":"D013739"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"1972-","companyName":"Actient Pharms","relationship":"Original Developer"},{"period":"present","companyName":"Besins Hlthcare","relationship":"Current Owner"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"0.17 hours","clearance":"24.5 mL/min/kg","bioavailability":"4%","fractionUnbound":"0.057%","volumeOfDistribution":"0.35 L/kg"},"publicationCount":101466,"therapeuticAreas":["Oncology"],"atcClassification":{"source":"DrugCentral","atcCode":"G03BA03","allCodes":["G03BA03","G03EA02"]},"biosimilarFilings":[],"originalDeveloper":"Actient Pharms","recentPublications":[],"companionDiagnostics":[],"genericManufacturers":15,"_genericFilersChecked":true,"genericManufacturerList":["Actavis Labs Ut Inc","Alembic","Amneal","Apotex","Cipla","Dr Reddys","Encube","Endo Operations","Lupin","Lupin Ltd","Padagis Israel","Strides Pharma Intl","Twi Pharms","Watson Labs","Xiromed"],"status":"approved","companyName":"Besins Hlthcare","companyId":"besins-hlthcare","modality":"Small molecule","firstApprovalDate":"1972","enrichmentLevel":4,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1972-07-13T00:00:00.000Z","mah":"ACTIENT PHARMS","brand_name_local":null,"application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":"1972-07-13T00:00:00.000Z","mah":"ACTIENT PHARMS","brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":"1972-07-13T00:00:00.000Z","mah":"ACTIENT PHARMS","brand_name_local":null,"application_number":null},{"country_code":"SA","regulator":"SFDA","status":"likely_approved","approval_date":"1972-07-13T00:00:00.000Z","mah":"ACTIENT PHARMS","brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":"1972-07-13T00:00:00.000Z","mah":"ACTIENT PHARMS","brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":"1972-07-13T00:00:00.000Z","mah":"ACTIENT PHARMS","brand_name_local":null,"application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2017-10-23T00:00:00.000Z","mah":"LUPIN LTD","brand_name_local":null,"application_number":"ANDA208061"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2019-11-19T00:00:00.000Z","mah":"ANTARES PHARMA INC","brand_name_local":null,"application_number":"NDA209863"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-04-16T00:00:00.000Z","mah":"XIROMED","brand_name_local":null,"application_number":"ANDA210835"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2025-07-15T00:00:00.000Z","mah":"ACTAVIS LABS UT INC","brand_name_local":null,"application_number":"ANDA205328"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2025-09-12T00:00:00.000Z","mah":"TOLMAR","brand_name_local":null,"application_number":"NDA206089"},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"EU","regulator":"EMA","status":"withdrawn","approval_date":null,"mah":null,"brand_name_local":"Intrinsa","application_number":"EMEA/H/C/000634"},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Intrinsa","application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"Un","currency":"USD","price_amount":"485.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":4,"withResults":1},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T00:41:06.720772+00:00","fieldsConflicting":15,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}