Annovera™
Nestorone + Ethinyl Estradiol One-Year Contraceptive Vaginal Ring, NES + EE Vaginal Ring
- User: Female
- Hormonal: Hormonal
-
Delivery type:
- Vaginal Ring
-
Intended Duration:
- Long-Acting
- Development Stage: Single-Country Approval
- Developer(s)/researcher(s): Population Council, NICHD, WHO, NIH, Gates Foundation, Avis and Clifford Barrus Medical Foundation, TherapeuticsMD
Details
- API: Nestorone, Ethinyl Estradiol
- Target: Estrogen Receptor, Progesterone Receptor
-
Mechanism of Action:
- Ovulation Inhibition
- Cervical Mucus Changes
- Endometrial Changes
- Inactive Materials: Silicone Elastomer
- Regimen: 13 Cycles - 3 Weeks In, 1 Week Out
- MPT: Not Potential MPT
- Promising Attributes: Annovera is long-acting, reversible, and minimally invasive. Clinical evidence suggests appropriate contraceptive efficacy for a user-controlled method.
Product Status
Single-Country Approval: United States
History
2003: Population Council announce the viability of a Nesterone-based one-year vaginal ring. Nesterone, or segesterone acetate, was developed by Population Council and first made available for medical use in 2000.
2006: Two identical Phase III trial protocols are initiated to evaluate the contraceptive efficacy of a novel hormonal vaginal ring intended to provide contraceptive protection for one year. Trial results would ultimately be published in 2019.
2018: Population Council and TherapeuticsMD receive FDA approval for Annovera, a 13-cycle (~1 year) vaginal ring containing Nestorone and ethinyl estradiol. Approval is based on the results of 17 total clinical trials (Ph I-III).
As of 2025, post-marketing evaluation of the product and secondary analysis of clinical trial data is ongoing, including recent clinical assessment of the impact of tampon co-usage, risk factors for expulsion, and product acceptability in Kenya and Zimbabwe.
Publications
doi: 10.1016/j.contraception.2019.07.145
doi: 10.1016/S2214-109X(19)30265-7
doi: 10.1016/j.jogn.2019.04.213
doi: 10.1016/j.contraception.2017.10.010
doi: 10.1016/j.contraception.2017.12.011
doi: 10.31899/rh9.1072
doi: 10.1016/S0039-128X(03)00140-5
doi: 10.1016/j.contraception.2025.111274
doi: 10.1016/j.ajog.2024.01.020
doi: 10.12688/gatesopenres.16315.1