The Food and Drug Administration today approved a new option in birth control: the vaginal ring, a small, flexible device coated with hormones.
Like the birth control pill, the device, known as the NuvaRing, releases estrogen and progestin to provide contraception. The difference from the pill lies in the delivery. While the birth control pill must be taken orally every day, NuvaRing releases the hormones continuously and in a lower dose than the pill once inserted.
A woman inserts the ring once a month and removes it after 21 days, or just before the start of her menstrual cycle. A visit to the gynecologist is not needed for insertion or removal.
"For someone who is comfortable inserting and removing tampons, this method would be no problem," says Dr. Philip D. Darney, one of the investigators in the NuvaRing trials conducted across the United States and Europe, and co-director of the Center for Reproductive Health Research & Policy at the University of California in San Francisco.
He says that NuvaRing, at two inches in diameter and an eight of an inch in cross-sectional diameter, was not uncomfortable to the vast majority of women in the trial.
"The ring is very soft. It can be squeezed together and settles in easily."
Small Numbers, to Start
Darney adds that expulsion of the ring with intercourse should not be a problem for most users. Still, the device can easily be removed before intercourse as long as it is not out for longer than 3 hours, in which case a back up method of birth control should be used for at least seven days.
Organon won't have enough NuvaRings for widespread sale to begin right away. Instead, the company plans to enroll up to 6,000 doctors in a pilot program that trains them in how to use NuvaRing and provides each a small number of the devices, according to a The Associated Press. Patients seeking the device this year will have to find doctors enrolled in the pilot program. Routine sales will begin by spring.
Organon would not reveal an exact price, but said NuvaRing should be comparable to name-brand birth control pills, which sell for about $30 a month.
Dr. Dena Hixson, a member of the FDA team that approved the product, says NuvaRing is "just as effective as birth control pills," which currently are said to be effective at preventing pregnancy in 98 percent to 99 percent of users.
The ring's side effects were found similar to the pill, including breast tenderness, breakthrough bleeding, vaginal discharge and the risk of deep vein thrombosis. In addition, some women may experience vaginal irritation or infection.
The ring also left women with the favorable side effects of the pill, including less bleeding, less cramping and less acne.
Who's it For?
Darney says continuation rates during the trials were higher with NuvaRing than the birth control pill, suggesting the method was appealing to women involved in the trial.
Darney also notes that part of the appeal may lie in the ring's simplicity.
"There's no need to worry about precise timing like you do with the pill. Once it's in, it's in. If it's in the vagina, it's doing its job."
"This is not going to be for everyone," says Darney. "I don't think it will replace birth control pills. Some women will like it because it's even a lower dose than the birth control. Others will like the idea of not taking a daily pill."