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Annovera (SEGESTERONE)
Annovera works by mimicking the natural estrogen in the body to prevent ovulation.
At a glance
| Generic name | SEGESTERONE |
|---|---|
| Sponsor | Mayne Pharma |
| Drug class | Estrogen [EPC] |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2018 |
Mechanism of action
CHCs lower the risk of becoming pregnant primarily by suppressing ovulation.
Approved indications
- pregnancy prevention
Boxed warnings
- WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, CHC should not be used by females who are over 35 years of age and smoke. [See Contraindications (4) and Warnings and Precautions (5.5) ]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Females over 35 years old who smoke should not use ANNOVERA. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. ( 4 )
Common side effects
- Headache, including migraine
- Nausea/vomiting
- Vulvovaginal mycotic infection/vaginal candidiasis
- Abdominal pain/lower/upper
- Dysmenorrhea
- Vaginal discharge
- UTI/cystitis/pyelonephritis/genitourinary tract infection
- Breast pain/tenderness/discomfort
- Metrorrhagia/menstrual disorder
- Diarrhea
- Genital pruritus
Drug interactions
- Aprepitant
- Barbiturates
- Bosentan
- Carbamazepine
- Efavirenz
- Felbamate
- Griseofulvin
- Oxcarbazepine
- Phenytoin
- Rifampin
- Rifabutin
- Rufinamide
Key clinical trials
- Vaginal Estradiol and Oral Guaifenesin in Clomiphene Ovulation Induction (NA)
- Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males (PHASE1)
- Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring (PHASE3)
- A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in Normal Cycling Women (PHASE2)
- Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring (PHASE2)
- Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception (PHASE2)
- Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men (PHASE1)
- The Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Annovera CI brief — competitive landscape report
- Annovera updates RSS · CI watch RSS
- Mayne Pharma portfolio CI