The first vaginal ring contraceptive that can be used for 1 year has been approved by the Food and Drug Administration.
The FDA granted approval of Annovera (segesterone acetate and ethinyl estradiol vaginal system), a reusable donut-shaped ring, to the Population Council. The nonbiodegradable, flexible vaginal system is placed in the vagina for 3 weeks followed by 1 week out of the vagina, at which time women may experience a menstrual period. This schedule is repeated every 4 weeks for 13 28-day menstrual cycles.
The contraceptive ring is washed and stored in a compact case for the 7 days when it is not in use. Annovera does not require refrigeration prior to dispensing and can withstand storage temperatures up to 30° C (86° F).
“Today’s approval builds on available birth control options,” said Victor Crentsil, MD, acting deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.
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 2%-4% of women may get pregnant during the first year they use Annovera.
Annovera carries a boxed warning regarding cigarette smoking and serious cardiovascular events. Women over age 35 who smoke should not use Annovera. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.
Annovera is contraindicated for women with a high risk of arterial or venous thrombotic diseases; a history of breast cancer or another estrogen- or progestin-sensitive cancer; liver tumors, acute hepatitis, or severe (decompensated) 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, according to an.
The most common side effects of Annovera are similar to those of other combined hormonal contraceptive products and include headache, nausea and vomiting, yeast infections, abdominal pain, dysmenorrhea, 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 Annovera.