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Ethinyl Estradiol / Norgestimate Oral Tablet
This combination oral contraceptive suppresses ovulation by inhibiting gonadotropin-releasing hormone, preventing follicle-stimulating hormone and luteinizing hormone surges.
This combination oral contraceptive suppresses ovulation by inhibiting gonadotropin-releasing hormone, preventing follicle-stimulating hormone and luteinizing hormone surges. Used for Contraception (prevention of pregnancy), Acne vulgaris (FDA-approved indication for certain formulations).
At a glance
| Generic name | Ethinyl Estradiol / Norgestimate Oral Tablet |
|---|---|
| Sponsor | University of Colorado, Denver |
| Drug class | Oral contraceptive (combined estrogen-progestin) |
| Target | Estrogen receptor and progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Contraception / Gynecology |
| Phase | FDA-approved |
Mechanism of action
Ethinyl estradiol is a synthetic estrogen that provides negative feedback on the hypothalamic-pituitary-ovarian axis, while norgestimate is a progestin that further suppresses LH surge and alters cervical mucus and endometrial environment. Together, these hormones prevent ovulation and create an inhospitable environment for sperm and embryo implantation.
Approved indications
- Contraception (prevention of pregnancy)
- Acne vulgaris (FDA-approved indication for certain formulations)
Common side effects
- Nausea
- Headache
- Breast tenderness
- Breakthrough bleeding
- Mood changes
- Venous thromboembolism
Key clinical trials
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- A Clinical Trial to Evaluate the Effect of Ulonivirine (MK-8507) on Heart Rhythm in Healthy Adults (MK-8507-012) (PHASE1)
- Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants (PHASE1)
- Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis (PHASE4)
- An Investigational Study to Evaluate the Cardiac Safety Assessment (TQTc Study) of ESK-001 (PHASE1)
- A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants. (PHASE1)
- Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT) (PHASE3)
- A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities (PHASE1)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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