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FC Patch Comparator Study
This study has been completed.
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00185354
  Purpose

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


Condition Intervention Phase
Contraception
 Drug: BAY86-5016, SH P00331F
Drug: SH P00331N
 Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Bleeding pattern and cycle control [ Time Frame: 13 cycles ]
  • Number of pregnancies [ Time Frame: 13 cycles ]

Secondary Outcome Measures:
  • Adverse events collection [ Time Frame: 13 cycles ]
  • Endometrial biopsy [ Time Frame: 13 cycles ]
  • Physical and gynecological exam [ Time Frame: 13 cycles ]

Enrollment: 400
Study Start Date: November 2004
Study Completion Date: April 2006
Arms Assigned Interventions
Arm 1: Experimental Drug: BAY86-5016, SH P00331F
Drug amount per patch: 0,9mg EE2 + 1,9mg gestodene (GSD)
Arm 2: Active Comparator Drug: SH P00331N
Drug amount per patch: 0,6mg EE2 + 6mg NGM

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications for using hormonal contraceptives
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185354

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to marketed products  This link exits the ClinicalTrials.gov site

Responsible Party: Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers: 91402, EudraCT: 2004-000821-31, 307969
Study First Received: September 13, 2005
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00185354  
Health Authority: Finland: National Agency for Medicines;   Austria: Federal Ministry for Health and Women;   France: Afssaps - French Health Products Safety Agency;   Spain: Spanish Agency of Medicines

Keywords provided by Bayer:
FC patch
comparator study

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 14, 2009



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