FC Patch Comparator Study
The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Multi-Center, Open, Randomized, Parallel Group Comparison of Cycle Control for Seven Cycles and Endometrial Safety in a Subgroup for Thirteen Cycles of Contraceptive Patch SH P00331F ( vs a Contraceptive Comparator Patch in 400 Healthy Female Volunteers)|
- Bleeding pattern and cycle control [ Time Frame: 13 cycles ]
- Number of pregnancies [ Time Frame: 13 cycles ]
- Adverse events collection [ Time Frame: 13 cycles ]
- Endometrial biopsy [ Time Frame: 13 cycles ]
- Physical and gynecological exam [ Time Frame: 13 cycles ]
|Study Start Date:||November 2004|
|Study Completion Date:||April 2006|
|Experimental: Arm 1||
Drug: BAY86-5016, SH P00331F
Drug amount per patch: 0,9mg EE2 + 1,9mg gestodene (GSD)
|Active Comparator: Arm 2||
Drug: SH P00331N
Drug amount per patch: 0,6mg EE2 + 6mg NGM
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.