Teva Women’s Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), today announced the findings from a Phase III pivotal trial of Quartette TM (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets), an investigational ascending-dose, extended-regimen oral contraceptive for the prevention of pregnancy that is currently under review by the U.S. Food and Drug Administration. These data were presented for the first time as a poster at the 68 th Annual Meeting of the American Society of Reproductive Medicine (ASRM).
The Phase III, multicenter, open-label, single arm study evaluated the efficacy and safety of Quartette TM over one year; 3,701 sexually active women 18 to 40 years old were enrolled and 2,144 completed the study. Data demonstrated Quartette TM is efficacious for the prevention of pregnancy and has a safety profile similar to that of other oral contraceptives. 1
“As a practicing OB/GYN, I continue to see women struggle with choosing an optimal contraceptive that fits their needs, so studying new contraceptive options with innovative designs is important,” said Dr. David J. Portman, MD, founder and principal investigator at the Columbus Center for Women’s Health Research, director of the Menopause Center of Columbus, clinical instructor at Ohio State University and an obstetrician/gynecologist with Portman OB/GYN. “The data presented at ASRM suggest that Quartette TM will be effective at preventing pregnancy.”
Quartette TM features a 91-day regimen, with an 84-day ascending ethinyl estradiol dose designed to minimize unscheduled or breakthrough bleeding, followed by period-stabilizing 10 mcg ethinyl estradiol pills during the traditional seven-day hormone-free interval.Efficacy in the study was measured using the Pearl Index (PI) to report pregnancy rates. The PI was 2.92 (95% CI, 2.26-3.72), based on 65 pregnancies that occurred after the onset of treatment and within 7 days after the last combination tablet in women 18 to 35 years old, and excluding cycles in which another method of birth control was used. Adverse effects were similar to those seen with other oral contraceptives. The most common treatment-related adverse effects were metrorrhagia (5.9%) and headache (4.5%). i “We are pleased to showcase these new data on a novel ascending-dose, extended regimen oral contraceptive for the prevention of pregnancy as part of the official ASRM program,” said Marty Berndt, vice president and general manager, US Brand Pharmaceuticals, Teva Women’s Health. “Quartette TM is an exciting advancement for women of reproductive age, as it offers them a unique contraceptive option. It also builds upon our heritage of providing women with innovative, extended-cycle contraceptive products, further reflecting our longtime commitment to women’s reproductive health.” About Quartette™ Quartette™ is an investigational extended regimen combination oral contraceptive in development for the prevention of pregnancy. Each 91-day cycle consists of ethinyl estradiol 20/ levonorgestrel 150 mcg for 42 days, ethinyl estradiol 25/ levonorgestrel 150 mcg for 21 days, ethinyl estradiol 30/ levonorgestrel 150 mcg for 21 days, and ethinyl estradiol 10 mcg for 7 days.