Efficacy and Safety Oral Contraceptive Study
Phase 3
Completed
- Conditions
- Contraception
- Interventions
- Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
- Registration Number
- NCT00185484
- Lead Sponsor
- Bayer
- Brief Summary
The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age
- Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1113
Inclusion Criteria
- Healthy woman requesting contraception
- Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive)
Exclusion Criteria
- Any conditions might interfere study outcome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) -
- Primary Outcome Measures
Name Time Method Rate of unintended pregnancies (Pearl index) 13 cycles of 28 days
- Secondary Outcome Measures
Name Time Method Physical and gynecological examination screening, cycle 6 and final examination Vital signs each visit Body weight each visit Cervical smear each visit