Annovera Vaginal Ring Approved for Contraception
August 10, 2018 – The U.S. FDA has approved Annovera (segesterone acetate/ethinyl estradiol vaginal system) to provide contraception for women of reproductive age. The product is manufactured by the Population Council in partnership with TherapeuticsMD, Inc., and is the first FDA-approved vaginal ring contraceptive that can be used for a full year.
Women can use Annovera at their discretion in four-week cycles, without the need for a medical procedure to insert the device. Once inserted, the ring should remain in place for three weeks, followed by one week of removal. Women may experience a withdrawal bleed in the fourth week after the ring has been removed. The ring must be washed after each use, and comes with a compact case for storage. It can be stored at temperatures of up to 30°C (86°F).
Based on clinical studies, up to 4% of women who use Annovera may experience an unplanned pregnancy during a full year of use. The FDA cautions that all hormonal contraceptives, like Annovera, carry serious risks such as stroke, heart attack, and liver disease. A black box warning indicates that smoking while using Annovera can increase the risk of adverse cardiovascular events. The product should not be used by women who have serious medical conditions, including:
- high risk of arterial or venous thrombotic diseases;
- breast cancer or other estrogen- or progestin-sensitive cancer;
- liver tumors, acute hepatitis, or severe cirrhosis;
- or undiagnosed abnormal uterine bleeding.
A nonprofit, international organization, the Population Council conducts research and advocacy to address public health concerns, particularly in developing nations. Plans for a United States launch of Annovera, which will occur through TherapeuticsMD, have not yet been announced.