Segesterone acetate and ethinyl estradiol vaginal system

(Annovera®)

Segesterone acetate and ethinyl estradiol vaginal system

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Drug updated on 5/17/2024

Dosage FormVaginal ring (intravaginal; 103 mg segesterone acetate and 17.4 mg ethinyl estradiol)
Drug ClassCombination hormonal contraceptives
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for use by females of reproductive potential to prevent pregnancy.

Summary
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  • The Segesterone Acetate and Ethinyl Estradiol Vaginal System (Annovera) is approved for use by females of reproductive potential to prevent pregnancy. Its safety profile is comparable to other combination hormonal contraceptives, with common adverse events including headache, nausea, vaginal discharge or infection, and abdominal pain.
  • Three studies regarding the effectiveness of Annovera as a contraceptive method provided comprehensive comparisons regarding its safety and acceptability among users compared to other methods like the NuvaRing.
  • The Segesterone Acetate and Ethinyl Estradiol Vaginal System exhibited favorable bleeding profiles, with most women experiencing scheduled bleeding/spotting. However, factors such as race (Black women) and education level influenced reports of unscheduled bleeding or spotting.
  • General acceptability and satisfaction levels towards contraceptive vaginal rings, including Annovera, were reported positively across studies, due in part to ease of insertion/removal along with improvements in sexual satisfaction.
  • Compared to other combination hormonal contraceptives, notably NuvaRing, Annovera showed similar safety profiles but had nuanced advantages, particularly regarding user control over the 21/7-day usage schedule, which may be more convenient for some users.
  • Special attention is advised for higher-risk groups, such as obese women who have a higher risk of VTE incidents. Racial disparities have also been noted, where Black women experienced more instances of unscheduled bleeding or spotting. This indicates that individual differences might affect outcomes, thus necessitating personalized counseling.

Product Monograph / Prescribing Information

Document TitleYearSource
Annovera (segesterone acetate and ethinyl estradiol vaginal system) Prescribing Information.2022TherapeuticsMD, Inc., Boca Raton, FL

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
General approaches to medical management of menstrual suppression.2022The American College of Obstetricians and Gynecologists (ACOG)