Last reviewed · How we verify
A Multicenter, Open-label, Three-arm, Active-controlled Study to Assess the Efficacy and Safety of the Oral Contraceptive SH T00186D (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) in Two Flexible Extended Regimens and a Conventional Regimen of YAZ in 1756 Healthy Females for 1 Year
The purpose of this study is to determine whether the study drug is safe and effective.
Details
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1887 |
| Start date | 2007-10 |
| Completion | 2009-11 |
Conditions
- Contraception
- Ovulation Inhibition
- Contraceptives, Oral
Interventions
- EE20/DRSP (BAY86-5300)
- EE20/DRSP (BAY86-5300)
- EE20/DRSP (YAZ, BAY86-5300)
Primary outcomes
- Pearl Index — Up to 1 year
The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) treatment arm, because the low sample size in these treatment arms (approximately. 200 subjects per group) did not allow a reliable PI calculation of these groups alone.
Countries
United States