Annovera, like its currently-on-the-market counterpart NuvaRing, is a hormonal contraceptive containing synthetic progestin and synthetic estrogen. It’s made of soft, flexible silicone and is about 2 ¼ inches in diameter. According to the FDA’s press announcement, the device is “a reusable donut-shaped (ring), non-biodegradable, flexible vaginal system” that’s placed in the vagina for three weeks at a time.
It’s then removed, washed, and stored for one week in a small case. (Women can do this themselves; they don’t need a doctor’s visit to do so.) During this time, a woman may experience a withdrawal bleed—or, in other words, get her period. The ring is reinserted after that week, and this schedule is repeated every four weeks for a full year.
That’s one way Annovera is different from the NuvaRing, which is thrown away and replaced with a new ring at the end of every month. That means fewer trips to the pharmacy, says Rebecca Simmons, PhD, assistant professor in the division of family planning at the University of Utah—which may translate to better, more uninterrupted protection.
“With the NuvaRing, you usually have to renew your prescription either every month or every three months,” says Simmons. “One of the main reasons women report not using their contraception regularly is because they have trouble getting access to the pharmacy. This allows for better availability, with a method that many women actually like.”
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Vaginal ring devices can “fill a gap” for women who want to use hormonal contraception but don’t want to—or can’t—take the pill, says Simmons. “Women like that it’s localized, that they have some control over it but it’s not something they have to think about every day,” she says. “Some people also report that they don’t experience the same sexual side effects with the ring that they do with other methods.”
Annovera is also different from other long-term birth control methods, like IUDs and implants, because women don’t have to visit the doctor’s office for removal and insertion. In a press release, TherapeuticsMD called the product “the first long-acting prescription birth control that is patient-controlled, procedure-free, and reversible.”
So how well does Annovera work? In clinical trials, between 2% and 4% of women became pregnant during the first year they used the vaginal ring. This makes it slightly less effective at preventing pregnancy than the implant and hormonal IUD (which both have a less-than-1% failure rate), but about even with the pill, the patch, and NuvaRing.
Nearly nine in 10 women surveyed during the ring’s phase three clinical trials said they were satisfied with Annovera as a method of contraception, and most said they experienced no change in sexual pleasure or frequency of sexual intercourse. Overall, the device ranked highly in terms of convenience, ease of use, and comfort.
Annovera can cause side effects, although those documented so far are similar to those of other hormonal contraceptives. These include headache or migraine, nausea or vomiting, yeast infections, abdominal pain, painful periods, breast tenderness, irregular bleeding, diarrhea, and genital itching.
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Like other hormonal contraception, Annovera also carries some serious risks related to cardiovascular events, such as blood clots and stroke. Women over 35 who smoke shouldn’t use Annovera, the FDA says, since smoking increases these risks.
The new vaginal ring also shouldn’t be used by women who have (or previously had) a high risk of blood clots, breast cancer or another hormone-sensitive cancer, liver disease, or other specific health conditions. It also hasn’t been tested in women with BMIs greater than 29.
The new ring was developed by the Population Council, a nonprofit research organization that confronts health and development issues around the world. The Population Council was previously involved in the development of five other contraceptive technologies, including ParaGard (a copper IUD), Mirena (a hormonal IUD), Norplant and Jadelle (contraceptive implants), and Progering (a vaginal ring for breastfeeding women).
It’s not yet known how much Annovera will cost, but TherapeuticsMD says it will provide reduced pricing to family planning clinics serving lower-income women. The Affordable Care Act also requires private health plans to provide coverage to certain contraceptives with no out-of-pocket costs—but since the Annovera may be considered a new class of contraception, it’s unclear how this regulation might apply.
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Annovera isn’t available to patients just yet: TherapeuticsMD has to ramp up commercial production of the device, and the company estimates that the ring will go on sale in late 2019 or early 2020. The FDA will also continue its research on Annovera (even after it’s on the market), to further evaluate its safety and effectiveness—especially when combined with tampon use or certain drugs.
In the meantime, Simmons says, there are several other birth control options for women to consider—both short- and long-term, hormonal and non-hormonal; there’s even now an FDA-approved birth-control app that uses body temperature to calculate when a woman needs to use protection. If you’re not sure what type of birth control might work best for you, or you’re concerned about the type you’re currently using, talk to your doctor.