FC Patch Comparator Study

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: BAY86-5016, SH P00331F; Drug: SH P00331N

• Registration Number: NCT00185354
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.

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: 2004-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2015-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 422

Inclusion Criteria

• Healthy female volunteer aged 18-35, smokers 18-30

Exclusion Criteria

• Contraindications for using hormonal contraceptives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	BAY86-5016, SH P00331F	-
Arm 2	SH P00331N	-

Primary Outcome Measures

Name	Time	Method
Number of pregnancies	13 cycles
Bleeding pattern and cycle control	13 cycles

Secondary Outcome Measures

Name	Time	Method
Adverse events collection	13 cycles
Physical and gynecological exam	13 cycles
Endometrial biopsy	13 cycles