LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (ethinyl estradiol)
This medication combines two hormones, levonorgestrel and ethinyl estradiol, to help females of reproductive age avoid pregnancy. It is used as a birth control method for women who are capable of becoming pregnant. By providing a steady dose of these hormones, it serves as an effective way to manage reproductive health and prevent conception.
How LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Works
This combined hormonal contraceptive works by preventing the release of an egg from the ovaries. By suppressing ovulation, the medication ensures that there is no egg available for fertilization, which effectively prevents pregnancy.
Details
- Status
- Prescription
- First Approved
- 2011-05-31
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Approval History
What LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Treats
1 indicationsLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pregnancy prevention
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning . • Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in women over 35 years old who smoke. ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 ) Cigarette smoking increases the risk of serious cardiovascu...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning . • Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in women over 35 years old who smoke. ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 ) 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. COCs, including levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )].
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340190 | CDAK539A12102 2025-521000-22-00 | Ph 1 | not yet recruiting | A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies |
| NCT03537768 | CCN013C | Ph 4 | terminated | Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg |
| NCT06727734 | UW 24-054 | Ph 3 | recruiting | Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception |
| NCT02722421 | 0234-16-FB 1R01HD085887-01A1 | Ph 2 | completed | Pharmacologic Strategies to Use the Levonorgestrel Implant in HIV-infected Women |
| NCT01686126 feMMe | feMMe | Ph 2 | active not recruiting | Improving the Treatment for Women With Early Stage Cancer of the Uterus |
| NCT06039826 | 18533 J1I-MC-GZBV | Ph 1 | completed | A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese |
| NCT06492889 | 8007 | Ph 2, Ph 3 | not yet recruiting | Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens |
| NCT02203331 results posted | 15832 2013-005090-53 | Ph 2 | completed | Bay98-7196, Dose Finding / POC Study |
| NCT01789879 | 0022-14-EP 1R21HD074462-01 | Ph 2 | completed | A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy |
| NCT00445887 results posted | GOG-0214 NCI-2009-00588, 10-01367 | Ph 2 | completed | Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer |
| NCT01623466 ATI-CL21 results posted | ATI-CL21 | Ph 1, Ph 2 | completed | Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches |
| NCT02480647 | 44827415200005404 | Ph 4 | completed | Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Endometriosis |
| NCT02599077 | FSantafeBogota | Ph 2, Ph 3 | suspended | Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas |
| NCT01570244 results posted | 1220.56 2011-006061-17 | Ph 1 | completed | Drug-drug Interaction of BI 201335 and Microgynon |
| NCT02159131 | 117011 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects |
| NCT01328184 results posted | 1245.41 2010-023432-16 | Ph 1 | completed | Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon |
| NCT00922233 results posted | 10139 | Ph 3 | completed | Pericoital Oral Contraception With Levonorgestrel |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL FDA Label Details
Indications & Usage
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL is indicated for the treatment of Pregnancy prevention.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning . • Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in women over 35 ye...
Track LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.