A Multicenter, Open-label, Single-arm Study to Investigate the Efficacy and Safety of the Oral Contraceptive YAZ (20 μg Ethinylestradiol, 3 mg Drospirenone) for 13 Cycles in 670 Healthy Chinese Female Volunteers.

Bayer0 sites675 target enrollmentDecember 2008

ConditionsContraception

InterventionsYAZ (SH T00186, BAY86-5300)

DrugsYAZ (SH T00186, BAY86-5300)

Overview

Phase: Phase 3
Intervention: YAZ (SH T00186, BAY86-5300)
Conditions: Contraception
Sponsor: Bayer
Enrollment: 675
Primary Endpoint: The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

January 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Bayer

Eligibility Criteria

Inclusion Criteria

•Healthy women between 18 and 45 requesting oral contraception.
•Smokers may not exceed 30 years of age.

Exclusion Criteria

•The use of steroidal oral contraceptives , or any drug that could alter oral contraception metabolism will be prohibited during the study.
•Pregnancy, lactation (less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment)
•Menstrual disorders suspicious of ovarian failure (e.g. oligomenorrhea, amenorrhea, hypomenorrhea
•Any disease or condition that may worsen under hormonal treatment
•Other contraceptive methods such as sterilization or IUD/IUS
•Substantial overweight (BMI \> 30 kg/m2).