The Food and Drug Administration has approved the Skyla intrauterine device.
The device is the first new IUD to be brought to the U.S. market in 12 years, Dr. Pamela A. Cyrus, vice president and head of U.S. medical affairs for Bayer HealthCare Pharmaceuticals, the device’s manufacturer, said in a press release.
Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg will be available by prescription the week of Feb. 11, according to the manufacturer.
Skyla "is more than 99% effective at preventing pregnancy," Dr. Anita L. Nelson, professor of obstetrics and gynecology at Harbor–UCLA Medical Center, Torrance, Calif., said in the Bayer statement. "Further, Skyla may be used by women whether or not they have ever had a child, representing an important new choice for women who don’t want to become pregnant for up to three years."
The approval of Skyla is supported by data from a phase III trial of 1,432 women aged 18-35 years who received the device. Nearly 40% (556 women) were nulliparous. The trial was a multicenter, multinational, randomized open-label study conducted in 11 countries in Europe, Latin America, the United States, and Canada. The trial excluded women less than 6 weeks post partum, those with a history of ectopic pregnancy, those with clinically significant ovarian cysts, and those with HIV or otherwise at high risk for sexually transmitted infections.
The pregnancy rate using the Pearl Index calculated based on 28-day equivalent exposure cycles was the primary efficacy endpoint used to assess contraceptive reliability. Skyla-treated women provided 15,763 evaluable 28-day cycle equivalents in the first year and 39,368 evaluable cycles over the 3-year treatment period.
The PI estimate for the first year of use based on the five pregnancies that occurred after the onset of treatment and within 7 days after Skyla removal or expulsion was 0.41 with a 95% upper confidence limit of 0.96. The cumulative 3-year pregnancy rate, based on 10 pregnancies, was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.
Of Skyla-treated women, 22% discontinued the study treatment because of an adverse event. Adverse reactions occurring in at least 5% of users were vulvovaginitis (20%), abdominal/pelvic pain (19%), acne/seborrhea (15%), ovarian cyst (13%), headache (12%), dysmenorrhea (9%), breast pain/discomfort (9%), increased bleeding (8%), and nausea (6%).
The Skyla T-body measures 28 mm x 30 mm, and the outer diameter of the placement tube is 3.8 mm. Women can become pregnant as soon as Skyla is removed. Based on study data, 77% of women who wanted to conceive became pregnant sometime in the first year after Skyla was removed.