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FDA Approves New Oral Contraceptive
Levonorgestrel/ethinyl estradiol tablets 97% effective in phase III trial (Mar. 29)
The FDA has approved Quartette tablets (levonorgestrel/ethinyl estradiol and ethinyl estradiol, Teva Pharmaceuticals) for the prevention of pregnancy. The product was designed to minimize breakthrough bleeding (BTB) between scheduled periods.
The agency’s approval was based on a development program that included results from phase I, II, and III clinical trials designed to evaluate the safety and efficacy of Quartette. The phase III clinical study, which involved more than 3,000 women, found that the product was 97% effective at preventing pregnancy. The most common adverse reactions in this study were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, increased weight, mood changes, anxiety/panic attack, breast pain, and migraines.
The primary clinical trial that evaluated the efficacy of Quartette also assessed BTB. BTB and unscheduled spotting decreased over successive 91-day cycles.
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) features a 91-day oral regimen, whereby the dose of estrogen increases at three distinct points over the first 84 days and the amount of progestin remains consistent; this is followed by 7 days of 10 mcg of ethinyl estradiol.
Source: Teva Pharmaceuticals; March 29, 2013.