Comprehensive overview of the recently FDA-approved contraceptive vaginal ring releasing segesterone acetate and ethinylestradiol: A new year-long, patient controlled, reversible birth control method

ABSTRACT

Introduction: This is an overview of the recently FDA-approved silicone elastomer combined hormonal contraceptive vaginal ring (CVR), which is used cyclically for up to 1 year, eliminating resupply challenges. This ring requires no refrigeration, simplifying the supply chain. Developed by the Population Council, this CVR will soon be marketed in the United States as Annovera™ by TherapeuticsMD.

Areas Covered: The composition of the elastomer ring and the chemical, pharmacokinetic and pharmacodynamic properties of both hormonal components are discussed. Results of the clinical trials of its efficacy, tolerability, safety, and acceptability follow. Finally, subanalyses from the clinical trials are presented to guide clinicians in counseling potential users.

Expert Opinion: This CVR introduces a new progestin – segesterone acetate (SA) – that has no androgenic or estrogenic action in vitro or in vivo, but has the highest anti-ovulatory potential of all available progestins. SA is paired with EE in an intravaginal elastomer ring, that is used cyclically (21 days in place/7 days removed) to provide 12 months (13 cycles) of contraception. This once-a-month, self-applied CVR offers a convenient, rapidly reversible, year-long contraception with efficacy and side effect profiles similar to other combined hormonal methods, for women with BMI < 29 kg/m².

KEYWORDS:

• Annovera
• birth control
• combined hormonal contraception
• contraceptive vaginal ring
• nestorone
• segesterone
• vaginal ring

Article Highlights

• This newly FDA-approved contraceptive vaginal ring (CVR) utilizing segesterone acetate (SA) and ethinylestradiol (EE) is used cyclically (21 days in place/7 days removed) for up to 13 cycles of use, thus overcoming supply access challenges women face when using other woman-controlled hormone methods.

• This new CVR does not require refrigeration, which will simplify and reduce costs for the supply chain.

• The failure rate (Pearl Index) for this ring is 2.98 pregnancies/100 women-years, which is comparable to other combined hormonal methods. It is not influenced by BMI, within the weight ranges of women included in the clinical trials.

• This CVR also preserves the cyclic scheduled bleeding that many women appreciate. Only 1.7% of women discontinued due to unacceptable bleeding patterns.

• Overall, the SA/EE CVR was well tolerated. Almost 90% of respondents said they were either ‘highly satisfied’ or ‘satisfied’ with the ring. Early discontinuation due to adverse events was 12.3%. Venous thromboembolism (VTE) occurred in four cases, most in women with identified risk factors for VTE, but the high rate of VTE triggered an FDA-mandated post-marketing study.

• This ring represents a hybrid method – one that is longer acting (one ring lasts 1 year), but is still user-controlled and provides monthly bleeding.

Declaration of interest

Anita L Nelson declares that she has received payments for research from Estetra, EvoFem, FHI (MonaLisa), Mathra, Sebela and honoraria for participation on advisory boards or speaker bureaus for Agile Therapeutics, AMAG, American Regent, Inc, Bayer Healthcare, CooperSurgical, Sebela, and Merck. She was the local principal investigator at her site in the NIH-sponsored clinical trials for Annovera™.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.