By Linda Carroll
(Reuters Health) – A new contraceptive vaginal ring prevents pregnancy for a year and allows women to have complete control over conception, according to a report that details the results of two clinical trials testing the safety and efficacy of the device.
While the device may become a real convenience for American women, its global impact may be even larger since it will offer women who have little access to pharmacies or electricity for refrigerators the ability to decide when they wish to become pregnant.
“This is a very exciting addition to the options for women to prevent unintended pregnancy,” said study coauthor Dr. Erika Banks, vice-chair of obstetrics and gynecology at the Albert Einstein and Montefiore Medical Center. “The advantages are huge in that women don’t have to go to the pharmacy every month and don’t have to have a refrigerator to store them in. Patients loved it.”
Other contraceptive rings don’t last as long and do need to be stored in refrigerators.
The new ring-shaped device is made of soft plastic and is around two inches in diameter. It prevents pregnancy through the slow release of the hormones progesterone and estrogen, in forms that don’t need to be refrigerated, Banks explained. “They are flexible and you can pinch the sides together and push them up into the vagina,” she added. “Once inside, it gets to be whatever shape the vagina is.”
Dubbed Annovera, the device was developed by the nonprofit Population Council and was approved by the Food and Drug Administration in August 2018. It will be sold in the U.S. market by TherapeuticsMD, Inc., starting later this year or in 2020. The company has not announced the price of Annovera but has agreed to provide significantly reduced pricing to family planning clinics serving lower-income women.
The Population Council is planning to make the device available to women in developing countries, which was the main audience it was designed for, said coauthor Ruth Merkatz, director of clinical development at the Population Council.
One strategy may be “trying to get companies in other parts of the world licensed to make it,” Merkatz said. “Our whole focus was women in the developing world. That’s why we worked so hard to develop it. It’s not easy to formulate a contraceptive – or any medication – with enough medication in it to last a full year and be effective without the need for refrigeration.”
While women are told they can take the rings out for two hours at a time, presumably for intercourse, “you can wear them while having sex,” Banks said. “Men don’t notice when they’re in there and the few who do notice it doesn’t seem to bother.”
The new device was tested in two large, identically designed trials, one at 15 U.S. academic and community sites and one at 12 U.S. and international academic and community sites. As reported in The Lancet Global Health, the trials were run between 2006 and 2009. The 2,265 participants, ages 18 to 40, were told they should wear the rings for 21 days and take them out for seven, thus mimicking the normal menstrual cycle. They were also told they could periodically take the rings out, but for no more than two hours at a time, since the efficacy of the contraceptive might be affected if the rings were removed for longer periods.
When the data from the trials were analyzed, the device turned out to be 97.5% effective, meaning that if 1,000 women used the device, 25 could become pregnant. The researchers followed up on 290 of the women and found that all had started to menstruate normally once they stopped using the rings, and 24 of the 38 who had wanted to become pregnant did so within six months of ring removal. The new study did not report on side effects from the ring.
The new device is “fantastic,” said Dr. Leena Nathan, an assistant clinical professor of obstetrics and gynecology at UCLA Health in Los Angeles. “I would offer this to my patients and encourage them to give it a try.”
A big advantage is that women don’t have to think about it once it’s inserted and they don’t need a doctor to insert it, Nathan said. “And it’s pretty easy to stop. If the woman doesn’t like it she can just pull it out.”
“It’s awesome that it works for a full year,” Nathan said. “This will change the landscape for us.”
SOURCE: http://bit.ly/2YUWR7V and http://bit.ly/2YUX5vN Lancet Global Health, online June 20, 2019.