The US Food and Drug Administration today approved segesterone acetate and ethinyl estradiol vaginal system (Annovera), which is a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

The segesterone acetate and ethinyl estradiol vaginal system is a reusable donut-shaped (ring), non-biodegradable, flexible vaginal system that is placed in the vagina for 3 weeks followed by 1 week out of the vagina, at which time women may experience a period (a withdrawal bleed). This schedule is repeated every 4 weeks for 1 year (13 28-day menstrual cycles).

“The FDA is committed to supporting innovation in women’s health and today’s approval builds on available birth control options,” states Victor Crentsil, MD, acting deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.

The segesterone acetate and ethinyl estradiol vaginal system is washed and stored in a compact case for the 7 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 the segesterone acetate and ethinyl estradiol vaginal system were studied in three open-label clinical trials with healthy women ranging from 18 to 40 years of age. Based on the results, about 2 to 4 women out of 100 women may get pregnant during the first year they use the segesterone acetate and ethinyl estradiol vaginal system.

All hormonal contraception carries serious risks. The segesterone acetate and ethinyl estradiol vaginal system carries a boxed warning relating to cigarette smoking and serious cardiovascular events. Women over 35 who smoke should not use the segesterone acetate and ethinyl estradiol vaginal system. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.

The segesterone acetate and ethinyl estradiol vaginal system is contraindicated and should not be used in women with:

• A high risk of arterial or venous thrombotic diseases;
• Current or history of breast cancer or other estrogen- or progestin-sensitive cancer;
• Liver tumors, acute hepatitis, or severe (decompensated) cirrhosis;
• Undiagnosed abnormal uterine bleeding;
• Hypersensitivity to any of the components; and
• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

The most common side effects in women using the segesterone acetate and ethinyl estradiol vaginal system are similar to those of other combined hormonal contraceptive products and include headache/migraine, nausea/vomiting, yeast infections, abdominal pain, dysmenorrhea (painful menstruation), breast tenderness, irregular bleeding, diarrhea and genital itching.

The FDA is requiring postmarketing studies to further evaluate the risks of venous thromboembolism, and the effects of CYP3A modulating drugs and tampon use on the pharmacokinetics of the segesterone acetate and ethinyl estradiol vaginal system.

The FDA granted approval of the segesterone acetate and ethinyl estradiol vaginal system to The Population Council, Inc.