- A contraceptive vaginal system using segesterone acetate and ethinyl estradiol (Annovera) is effective for 13 cycles of use, according to findings from 2 pivotal phase 3 trials .
- The FDA approved the system in 2018, but these studies included non-US sites as well.
Why this matters
- The ring-shaped system does not require refrigeration when not being used, requires only annual refills.
- Pearl index: 2.98 per woman-years (95% CI, 2.13-4.06), which authors say is well within the range indicating efficacy.
- Index was worst among youngest women, black women, and those who removed the system longer than 2 hours during the active 21-day time frame.
- System was 97.5% effective.
- Return to menses or desired conception after cessation occurred among all 290 follow-up participants within 6 months.
- Adverse events included headache, fatigue, nausea, vaginal discharge, abdominal pain.
- Identically designed, multicenter, open-label phase 3 trials at US sites (15; December 19, 2006 to October 9, 2009) and at US and international sites (12; November 1, 2006 to July 2, 2009); enrolled 2278 healthy, sexually active, nonpregnant people ages 18-40 years.
- Funding: NIH, WHO, others.
- Exclusion of women with BMI >29.0 kg/m2 might limit generalizability.