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Segesterone Acetate and Ethinyl Estradiol
A progestin-estrogen combination that suppresses ovulation and alters cervical mucus and endometrial environment to prevent pregnancy.
A progestin-estrogen combination that suppresses ovulation and alters cervical mucus and endometrial environment to prevent pregnancy. Used for Contraception in women of reproductive potential.
At a glance
| Generic name | Segesterone Acetate and Ethinyl Estradiol |
|---|---|
| Also known as | Annovera |
| Sponsor | TherapeuticsMD |
| Drug class | Hormonal contraceptive |
| Target | Progesterone receptor (segesterone acetate); estrogen receptor (ethinyl estradiol) |
| Modality | Small molecule |
| Therapeutic area | Contraception / Women's Health |
| Phase | FDA-approved |
Mechanism of action
Segesterone acetate is a selective progesterone receptor agonist that works synergistically with ethinyl estradiol (a synthetic estrogen) to inhibit the luteinizing hormone (LH) surge required for ovulation. The combination also thickens cervical mucus to impede sperm penetration and alters the endometrium to prevent implantation, providing multiple layers of contraceptive protection.
Approved indications
- Contraception in women of reproductive potential
Common side effects
- Headache
- Nausea
- Breast tenderness
- Irregular bleeding/spotting
- Mood changes
Key clinical trials
- Vaginal Estradiol and Oral Guaifenesin in Clomiphene Ovulation Induction (NA)
- The Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol (PHASE1)
- Annovera™ Drug-Drug Interaction Study (PHASE1)
- The Vaginal Health Trial (PHASE3)
- Safety and Efficacy of a Contraceptive Vaginal Ring Delivering Nestorone® and Ethinyl Estradiol (PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Segesterone Acetate and Ethinyl Estradiol CI brief — competitive landscape report
- Segesterone Acetate and Ethinyl Estradiol updates RSS · CI watch RSS
- TherapeuticsMD portfolio CI