Drug updated on 9/4/2024
Dosage Form | Vaginal ring (intravaginal; 103 mg segesterone acetate and 17.4 mg ethinyl estradiol) |
Drug Class | Combination hormonal contraceptives |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for use by females of reproductive potential to prevent pregnancy.
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Summary
- Annovera (segesterone acetate and ethinyl estradiol vaginal system) is indicated for use by females of reproductive potential to prevent pregnancy.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- General satisfaction with NuvaRing® was reported between 80-90%, indicating high user satisfaction. However, mixed results were observed regarding the continuation of use.
- The SA/EE CVS demonstrated good cycle control over 13 cycles, with a minimal discontinuation rate due to unacceptable bleeding (1.8%). Scheduled bleeding/spotting was reported by 98% of participants, with unscheduled bleeding/spotting ranging from 13.2% to 21.7% per cycle.
- No significant differences in effectiveness among different population types and subgroups were explicitly reported in the provided data.
- The most commonly reported adverse events for the SA/EE contraceptive vaginal system (CVS) were headache (26%), nausea (18%), vaginal discharge/vulvovaginal mycotic infection (10%), and abdominal pain (10%), with a low discontinuation rate due to these complaints (<1.5%). Venous thromboembolism (VTE) occurred in four women (0.2%), with three having predisposing risk factors.
- Partial expulsions were observed in 19.5% of cycles, and complete expulsions occurred in 7% of cycles, with the highest incidence during the initial cycle. Focused safety studies revealed no major safety concerns.
- Studies indicated that Black women were more likely to report unscheduled bleeding/spotting compared to White women, while women with fewer years of schooling were less likely to report unscheduled bleeding/spotting compared to college graduates.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Annovera (segesterone acetate and ethinyl estradiol vaginal system) Prescribing Information. | 2022 | TherapeuticsMD, Inc., Boca Raton, FL |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Acceptability and Satisfaction of Contraceptive Vaginal Rings in Clinical Studies: A Systematic Review and Narrative Synthesis. | 2021 | Frontiers in Global Women’s Health |
Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation. | 2019 | Contraception |
Bleeding profile associated with 1-year use of the segesterone acetate/ethinyl estradiol contraceptive vaginal system: pooled analysis from Phase 3 trials. | 2019 | Contraception |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
General approaches to medical management of menstrual suppression. | 2022 | The American College of Obstetricians and Gynecologists (ACOG) |