Teva announced findings from a Phase 3 pivotal trial of Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for the prevention of pregnancy.
The multicenter, open-label, single arm study evaluated the efficacy and safety of Quartette over one year; 3,701 sexually active women 18–40 years old were enrolled and 2,144 completed the study. Data demonstrated Quartette is efficacious for the prevention of pregnancy and has a safety profile similar to that of other oral contraceptives.
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 18–35 years old, and excluding cycles in which another method of birth control was used.
Quartette is an investigational ascending-dose, extended regimen combination oral contraceptive. Each 91-day cycle consists of ethinyl estradiol 20mcg/ levonorgestrel 150mcg for 42 days, ethinyl estradiol 25mcg/ levonorgestrel 150mcg for 21 days, ethinyl estradiol 30mcg/ levonorgestrel 150mcg for 21 days, and ethinyl estradiol 10mcg for 7 days.
For more information call (215) 591-3000 or visit www.tevapharm.com.