FDA Approves Hormonal Contraceptive Vaginal Ring That Can Be Used Up to 1 Year

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

“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.

Annovera is a flexible, non-biodegradable ring that is placed in the vagina for 3 weeks and then removed for 1 week, during which patients may experience a period. The ring is then replaced and the cycle is repeated every 4 weeks for up to a year (thirteen 28-day menstrual cycles).

The approval was based in part on data from 3 open-label clinical trials conducted among healthy women aged 18 to 40 years. These results show that 2% to 4% of women may get pregnant during the first year of using Annovera. The FDA announcement did not specify the “perfect use” and “typical use” failure rates for women using Annovera.

Annovera 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 cirrhosis;
• Undiagnosed abnormal uterine bleeding;
• Hypersensitivity to any of the components of Annovera; and
• Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

The most common reported side effects of Annovera are similar to those of other hormonal contraceptives and include headache/migraine, nausea/vomiting, yeast infections, abdominal pain, dysmenorrhea (painful menstruation), breast tenderness, irregular bleeding, diarrhea and genital itching.

The FDA has added a requirement for The Population Council, Inc. to conduct postmarketing studies to further evaluate the risks of venous thromboembolism, and the effects of CYP3A modulating drugs and tampon use on the pharmacokinetics of Annovera.