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Delestrogen (ESTRADIOL VALERATE)
Delestrogen works by binding to estrogen receptors in the body, mimicking the effects of natural estrogen.
At a glance
| Generic name | ESTRADIOL VALERATE |
|---|---|
| Sponsor | Ph Health |
| Drug class | Estrogen |
| Target | Estrogen receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1954 |
Mechanism of action
Think of estrogen as a key that unlocks certain processes in the body. Delestrogen is a synthetic version of that key, which helps to alleviate symptoms of estrogen deficiency, such as hot flashes and vaginal dryness. By binding to estrogen receptors, Delestrogen helps to restore balance to the body's hormonal system.
Approved indications
- Advanced Prostatic Carcinoma
- Contraception
- Female hypogonadism syndrome
- Menopausal flushing
- Metastatic Prostate Carcinoma
- Primary ovarian failure
Boxed warnings
- WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. [See Contraindications ( 4 ).] WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. • Women over 35 years old who smoke should not use Natazia. ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )
Common side effects
- Deep and superficial venous thrombosis
- Pulmonary embolism
- Thrombophlebitis
- Myocardial infarction
- Stroke
- Increase in blood pressure
- Breast cancer
- Endometrial cancer
- Ovarian cancer
- Pancreatitis
- Enlargement of hepatic hemangiomas
- Cholestatic jaundice
Key clinical trials
- Menopausal Hormones and Sympathetic Activation (PHASE4)
- Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients (PHASE3)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial (PHASE2)
- Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea (PHASE3)
- Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors (PHASE1,PHASE2)
- A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (PHASE1)
- Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 Negative Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment (PHASE2)
- Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |