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.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Study Completion: 2006-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2014-12-31

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
Body weight	each visit
Cervical smear	each visit
Vital signs	each visit