{"id":"ethinyl-estradiol-and-levonorgestrel","rwe":[],"tags":[],"phase":"phase_1","safety":{"boxedWarnings":["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 who are over 35 years old and smoke should not use AMETHIA tablets. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use."],"drugInteractions":["7. DRUG INTERACTIONS No drug-drug interaction studies were conducted with AMETHIA tablets. Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs. ( 7.1 ) 7.1 Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Products If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John's wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors : Significant changes (increase or decrease) in the plasma levels of the estrogen and progestin have been noted in some cases of co-administration of HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors. Antibiotics : There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids. Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. 7.2 Increase in Plasma Levels of Estradiol Associated with Co-Administered Drugs Co-administration of atorvastatin and certain COCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels. 7.3 Concomitant Use with Hepatitis C Vaccine (HCV) Combination Therapy – Liver Enzyme Elevation Do not co-administer AMETHIA tablets with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions (5.4) ] . 7.4 Changes in Plasma Levels of Co-Administered Drugs COCs containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. COCs have been shown to significantly decrease plasma concentrations of lamotrigine likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations."],"commonSideEffects":[{"effect":"Dysmenorrhoea","drugRate":"17.0%","placeboRate":"","totalAtRisk":558,"totalAffected":95,"trialsReporting":2},{"effect":"Acne","drugRate":"11.5%","placeboRate":"","totalAtRisk":558,"totalAffected":64,"trialsReporting":2},{"effect":"Cervical dysplasia","drugRate":"10.8%","placeboRate":"","totalAtRisk":558,"totalAffected":60,"trialsReporting":2},{"effect":"Headache","drugRate":"8.4%","placeboRate":"","totalAtRisk":558,"totalAffected":47,"trialsReporting":2},{"effect":"Abdominal pain","drugRate":"7.9%","placeboRate":"","totalAtRisk":558,"totalAffected":44,"trialsReporting":2},{"effect":"Cystitis","drugRate":"7.2%","placeboRate":"","totalAtRisk":558,"totalAffected":40,"trialsReporting":2},{"effect":"Nasopharyngitis","drugRate":"7.0%","placeboRate":"","totalAtRisk":558,"totalAffected":39,"trialsReporting":2},{"effect":"Ovarian cyst","drugRate":"6.6%","placeboRate":"","totalAtRisk":558,"totalAffected":37,"trialsReporting":2},{"effect":"Vulvovaginal candidiasis","drugRate":"5.0%","placeboRate":"","totalAtRisk":558,"totalAffected":28,"trialsReporting":2},{"effect":"Pelvic pain","drugRate":"4.7%","placeboRate":"","totalAtRisk":558,"totalAffected":26,"trialsReporting":2},{"effect":"Urinary tract infection","drugRate":"4.5%","placeboRate":"","totalAtRisk":558,"totalAffected":25,"trialsReporting":2},{"effect":"Abdominal pain lower","drugRate":"3.8%","placeboRate":"","totalAtRisk":558,"totalAffected":21,"trialsReporting":2},{"effect":"Procedural pain","drugRate":"3.6%","placeboRate":"","totalAtRisk":558,"totalAffected":20,"trialsReporting":2},{"effect":"Vaginal infection","drugRate":"3.4%","placeboRate":"","totalAtRisk":558,"totalAffected":19,"trialsReporting":2},{"effect":"Metrorrhagia","drugRate":"3.4%","placeboRate":"","totalAtRisk":558,"totalAffected":19,"trialsReporting":2},{"effect":"Nausea","drugRate":"3.2%","placeboRate":"","totalAtRisk":558,"totalAffected":18,"trialsReporting":2},{"effect":"Vulvovaginal mycotic infection","drugRate":"3.2%","placeboRate":"","totalAtRisk":558,"totalAffected":18,"trialsReporting":2},{"effect":"Vaginal discharge","drugRate":"3.2%","placeboRate":"","totalAtRisk":558,"totalAffected":18,"trialsReporting":2},{"effect":"Bacterial vaginosis","drugRate":"6.5%","placeboRate":"","totalAtRisk":279,"totalAffected":18,"trialsReporting":1},{"effect":"Weight increased","drugRate":"3.0%","placeboRate":"","totalAtRisk":558,"totalAffected":17,"trialsReporting":2},{"effect":"Back pain","drugRate":"2.5%","placeboRate":"","totalAtRisk":558,"totalAffected":14,"trialsReporting":2},{"effect":"Vaginal haemorrhage","drugRate":"2.5%","placeboRate":"","totalAtRisk":558,"totalAffected":14,"trialsReporting":2},{"effect":"Genital haemorrhage","drugRate":"2.2%","placeboRate":"","totalAtRisk":558,"totalAffected":12,"trialsReporting":2},{"effect":"Oropharyngeal pain","drugRate":"2.2%","placeboRate":"","totalAtRisk":558,"totalAffected":12,"trialsReporting":2},{"effect":"Menorrhagia","drugRate":"2.0%","placeboRate":"","totalAtRisk":558,"totalAffected":11,"trialsReporting":2},{"effect":"Tonsillitis","drugRate":"1.8%","placeboRate":"","totalAtRisk":558,"totalAffected":10,"trialsReporting":2},{"effect":"Smear cervix abnormal","drugRate":"1.8%","placeboRate":"","totalAtRisk":558,"totalAffected":10,"trialsReporting":2},{"effect":"Gastritis","drugRate":"1.6%","placeboRate":"","totalAtRisk":558,"totalAffected":9,"trialsReporting":2},{"effect":"Acute tonsillitis","drugRate":"1.6%","placeboRate":"","totalAtRisk":558,"totalAffected":9,"trialsReporting":2},{"effect":"Bronchitis","drugRate":"1.6%","placeboRate":"","totalAtRisk":558,"totalAffected":9,"trialsReporting":2},{"effect":"Vaginitis bacterial","drugRate":"3.2%","placeboRate":"","totalAtRisk":279,"totalAffected":9,"trialsReporting":1},{"effect":"Human papilloma virus test positive","drugRate":"1.6%","placeboRate":"","totalAtRisk":558,"totalAffected":9,"trialsReporting":2},{"effect":"Wisdom teeth removal","drugRate":"1.6%","placeboRate":"","totalAtRisk":558,"totalAffected":9,"trialsReporting":2},{"effect":"Gastrooesophageal reflux disease","drugRate":"1.4%","placeboRate":"","totalAtRisk":558,"totalAffected":8,"trialsReporting":2},{"effect":"Coital bleeding","drugRate":"1.4%","placeboRate":"","totalAtRisk":558,"totalAffected":8,"trialsReporting":2},{"effect":"Toothache","drugRate":"1.3%","placeboRate":"","totalAtRisk":558,"totalAffected":7,"trialsReporting":2},{"effect":"Vomiting","drugRate":"1.3%","placeboRate":"","totalAtRisk":558,"totalAffected":7,"trialsReporting":2},{"effect":"Gastroenteritis","drugRate":"1.3%","placeboRate":"","totalAtRisk":558,"totalAffected":7,"trialsReporting":2},{"effect":"Influenza","drugRate":"1.3%","placeboRate":"","totalAtRisk":558,"totalAffected":7,"trialsReporting":2},{"effect":"Vertigo","drugRate":"1.1%","placeboRate":"","totalAtRisk":558,"totalAffected":6,"trialsReporting":2},{"effect":"Hypothyroidism","drugRate":"1.1%","placeboRate":"","totalAtRisk":558,"totalAffected":6,"trialsReporting":2},{"effect":"Abdominal pain upper","drugRate":"1.1%","placeboRate":"","totalAtRisk":558,"totalAffected":6,"trialsReporting":2},{"effect":"Irritability","drugRate":"1.1%","placeboRate":"","totalAtRisk":558,"totalAffected":6,"trialsReporting":2},{"effect":"Pyrexia","drugRate":"1.1%","placeboRate":"","totalAtRisk":558,"totalAffected":6,"trialsReporting":2},{"effect":"Vulvitis","drugRate":"1.1%","placeboRate":"","totalAtRisk":558,"totalAffected":6,"trialsReporting":2},{"effect":"Vulvovaginitis","drugRate":"1.1%","placeboRate":"","totalAtRisk":558,"totalAffected":6,"trialsReporting":2},{"effect":"Vulvovaginitis streptococcal","drugRate":"1.1%","placeboRate":"","totalAtRisk":558,"totalAffected":6,"trialsReporting":2},{"effect":"Breast pain","drugRate":"1.1%","placeboRate":"","totalAtRisk":558,"totalAffected":6,"trialsReporting":2},{"effect":"Breast tenderness","drugRate":"1.1%","placeboRate":"","totalAtRisk":558,"totalAffected":6,"trialsReporting":2},{"effect":"Skin disorder","drugRate":"1.1%","placeboRate":"","totalAtRisk":558,"totalAffected":6,"trialsReporting":2}],"contraindications":["4. CONTRAINDICATIONS AMETHIA tablets are contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: ­Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ] . ­Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ] . ­Have cerebrovascular disease [see Warnings and Precautions (5.1) ]. ­Have coronary artery disease [see Warnings and Precautions (5.1) ] . ­Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1) ] . ­ Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ] . ­ Have uncontrolled hypertension [see Warnings and Precautions (5.5) ] . ­Have diabetes with vascular disease [see Warnings and Precautions (5.7) ] . ­Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.8) ] . Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.9) ] . Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.2) ] . Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6) ] . Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.10) and Use in Specific Populations (8.1) ] . Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.4) ]. A high risk of arterial or venous thrombotic diseases ( 4 ) Undiagnosed abnormal genital bleeding ( 4 ) Breast cancer or other estrogen- or progestin-sensitive cancer ( 4 ) Liver tumors or liver disease ( 4 ) Pregnancy ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )"]},"status":"active","trials":["NCT00920985","NCT00483535","NCT03043924","NCT03675581","NCT00764881","NCT02362711","NCT00196326","NCT02002260","NCT03210246","NCT03984825","NCT01714193","NCT00318799","NCT01414530","NCT01968135","NCT06188026","NCT03662516","NCT03249402","NCT00781456","NCT05058872","NCT01236768","NCT02257671","NCT02404038","NCT00006324","NCT04267250","NCT02751385","NCT06657105","NCT04230070","NCT01297179","NCT04142762","NCT00827632","NCT06354257","NCT04194905","NCT00447863","NCT04972396","NCT01570244","NCT01170390","NCT00196313","NCT01137708","NCT07074327","NCT02159326","NCT00909857","NCT05505162","NCT06799884","NCT00117273","NCT02531321","NCT04131517","NCT04018274","NCT00394771","NCT03193307","NCT01291004"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"aiSummary":"","brandName":"ethinyl estradiol and levonorgestrel","companyId":"proteostasis-therapeutics-inc","ecosystem":[],"mechanism":{"drugClass":"","explanation":"1. INDICATIONS AND USAGE AMETHIA tablets are indicated for use by women to prevent pregnancy. AMETHIA tablets are an estrogen/progestin COC indicated for use by women to prevent pregnancy. ( 1 )","oneSentence":"12.1 Mechanism of action COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation."},"commercial":null,"references":[],"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T11:18:20.529017+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"companyName":"Proteostasis Therapeutics, Inc.","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"ethinyl estradiol and levonorgestrel","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00920985","phase":"Phase 3","title":"Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal 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Follicle","completionDate":"2012-03-31"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"","dosage_text":"2. DOSAGE AND ADMINISTRATION Take one tablet by mouth at the same time every day. The dosage of AMETHIA tablets is one white tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one light blue ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, AMETHIA tablets must be taken exactly as directed and at intervals not exceeding 24 hours. Instruct the patient to begin taking AMETHIA tablets on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first white tablet is taken that day. One white tablet should be taken daily for 84 consecutive days, followed by one light blue tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until a white tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the light blue tablets are taken. Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of AMETHIA tablets, following the same schedule: 84 days taking a white tablet followed by 7 days taking a blue tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a white tablet daily for 7 consecutive days. If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider. For patient instructions regarding missed pills, see FDA-Approved Patient Labeling. For postpartum women who are not breastfeeding, start AMETHIA tablets no earlier than four to six weeks postpartum due to increased risk of thromboembolism. If the patient starts on AMETHIA tablets postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken a white tablet for 7 consecutive days. Take one tablet daily by mouth at the same time every day for 91 days. ( 2 )"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Other"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":5,"visitCount":1,"trialStats":{"total":2,"withResults":1},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T11:18:20.529017+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}