Reusable contraceptive ringSeptember 14, 2018
For yearlong use, the US Food and Drug Administration approved segesterone acetate and ethinyl estradiol vaginal system (Annovera), the first vaginal ring contraceptive that can be used for an entire year.
Annovera is a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy. The donut-shaped reusable ring is non-biodegradable, a flexible vaginal system that is placed in the vagina for three weeks followed by one week out of the vagina, at which time women may experience a withdrawal bleed. This schedule is repeated every four weeks for one year (thirteen 28-day menstrual cycles).
Annovera is washed and stored in a compact case for the seven days not in use. It does not require refrigeration prior to dispensing and can withstand storage temperatures up to 30°C (86°F).
The efficacy and safety of Annovera were studied in three, open-label clinical trials with healthy women ranging from 18 to 40 years of age. Based on the results, about two to four women out of 100 women may get pregnant during the first year they use Annovera.
Annovera carries a boxed warning relating to cigarette smoking and serious cardiovascular events. Women over 35 who smoke should not use Annovera. Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use.
The marketing approval of Annovera was granted to The Population Council, Inc. The Population Council, through its distribution partner TherapeuticsMD, currently expects to make Annovera fully available in late 2019 or early 2020.