HealthDay News — The FDA has approved Sklya, a new low-dose levonorgestrel-releasing intrauterine device from Bayer HealthCare to prevent pregnancy for up to three years.
Skyla is the first new IUD to win FDA approval in more than 10 years, the drug maker said in a press release.
The contraceptive is a 28 mm × 30 mm flexible, plastic, T-shaped device and contains 13.5 mg of the hormone levonorgestrel. It is inserted using a 3.8 mm-diameter tube. A slow, low-dose of levonorgestrel is locally released in the uterus, with only small amounts of the hormone entering the bloodstream.
Regulatory approval was based on data from a multinational, randomized open-label Phase 3 trial involving 1,432 women in the U.S., Canada, Europe, and Latin America. A total of 10 pregnancies occurred in the trial (0.9 per 100 participants; 95% CI 1.7 per 100 participants), for a 99% effectiveness rate in preventing pregnancy.
Skyla was well tolerated, with no unexpected adverse events. Approximately 22% of trial participants had the device removed due to vulvovaginitis (20.2% of users), abdominal or pelvic pain (18.9%), acne or seborrhea (15%), ovarian cyst (13.2%), headache (12.4%), dysmenorrhea (8.6%), breast pain or discomfort (8.6%), increased bleeding (7.8%) and nausea (5.5%).
There were low incidences of ectopic pregnancy, pelvic inflammatory disease, expulsion of the device from the uterus and uterine perforation.
Healthcare providers should advise patients that Skyla may cause irregular periods and longer menstrual flow accompanied by frequent spotting or light bleeding during the first three to six months after insertion. These effects usually lessen thereafter. Rarely, menstruation may stop altogether, Bayer said.