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Vaginal Ring Contraceptive Remains Effective for 1 Year

Vaginal Ring Contraceptive Remains Effective for 1 Year The first vaginal ring contraceptive that women can use for a full year has received FDA approval. In comparison, a contraceptive ring currently marketed in the United States has to be replaced monthly. Hallie Easley/Population Council Made of soft, nonbiodegradable silicone, the contraceptive ring prevents pregnancy by releasing a novel progestin, segesterone acetate, and the widely used estrogen, ethinyl estradiol. The product, which will be sold under the brand name Annovera, was developed by researchers at the Population Council, a New York City–based nongovernmental organization that studies international health and development issues. Women don’t need a health professional’s assistance to insert the ring into their vagina. It’s left in place for 21 days and removed for 7 days, when a woman’s period may begin. Each ring can be used for thirteen 28-day menstrual cycles. The ring doesn’t need refrigeration, and it can be stored at temperatures up to 86°F—important factors for use in low-resource regions of the world. Approval was based in part on data from 17 clinical trials, including 2 pivotal phase 3 trials. About 2300 women aged 18 to 40 years were enrolled in the phase 3 studies at 27 sites in the United States, Latin America, Europe, and Australia. They were instructed to use the contraceptive ring for 1 full year. Data from the trials showed the ring is 97.3% effective in preventing pregnancy when used as directed. In a subset of women in the phase 3 trials, 89% said they were satisfied with the ring as a contraceptive method. Common adverse events were headache and nausea. Yeast infections, abdominal pain, dysmenorrhea, breast tenderness, and irregular bleeding also have been reported. In addition, Annovera has a boxed warning about the increased risk of serious cardiovascular events in women who smoke cigarettes while they’re using combination hormonal contraceptives. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Vaginal Ring Contraceptive Remains Effective for 1 Year

JAMA , Volume 320 (11) – Sep 18, 2018

Vaginal Ring Contraceptive Remains Effective for 1 Year

Abstract

The first vaginal ring contraceptive that women can use for a full year has received FDA approval. In comparison, a contraceptive ring currently marketed in the United States has to be replaced monthly. Hallie Easley/Population Council Made of soft, nonbiodegradable silicone, the contraceptive ring prevents pregnancy by releasing a novel progestin, segesterone acetate, and the widely used estrogen, ethinyl estradiol. The product, which will be sold under the brand name Annovera, was developed...
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Publisher
American Medical Association
Copyright
Copyright © 2018 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2018.13299
Publisher site
See Article on Publisher Site

Abstract

The first vaginal ring contraceptive that women can use for a full year has received FDA approval. In comparison, a contraceptive ring currently marketed in the United States has to be replaced monthly. Hallie Easley/Population Council Made of soft, nonbiodegradable silicone, the contraceptive ring prevents pregnancy by releasing a novel progestin, segesterone acetate, and the widely used estrogen, ethinyl estradiol. The product, which will be sold under the brand name Annovera, was developed by researchers at the Population Council, a New York City–based nongovernmental organization that studies international health and development issues. Women don’t need a health professional’s assistance to insert the ring into their vagina. It’s left in place for 21 days and removed for 7 days, when a woman’s period may begin. Each ring can be used for thirteen 28-day menstrual cycles. The ring doesn’t need refrigeration, and it can be stored at temperatures up to 86°F—important factors for use in low-resource regions of the world. Approval was based in part on data from 17 clinical trials, including 2 pivotal phase 3 trials. About 2300 women aged 18 to 40 years were enrolled in the phase 3 studies at 27 sites in the United States, Latin America, Europe, and Australia. They were instructed to use the contraceptive ring for 1 full year. Data from the trials showed the ring is 97.3% effective in preventing pregnancy when used as directed. In a subset of women in the phase 3 trials, 89% said they were satisfied with the ring as a contraceptive method. Common adverse events were headache and nausea. Yeast infections, abdominal pain, dysmenorrhea, breast tenderness, and irregular bleeding also have been reported. In addition, Annovera has a boxed warning about the increased risk of serious cardiovascular events in women who smoke cigarettes while they’re using combination hormonal contraceptives.

Journal

JAMAAmerican Medical Association

Published: Sep 18, 2018

Keywords: contraceptive agents,vaginal rings

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