FC Patch Comparator Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185354
First received: September 13, 2005
Last updated: December 11, 2008
Last verified: December 2008
  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 3

Study Type: Interventional
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)

Resource links provided by NLM:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185354

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

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00185354     History of Changes
Other Study ID Numbers: 91402, EudraCT: 2004-000821-31, 307969
Study First Received: September 13, 2005
Last Updated: December 11, 2008
Health Authority: Finland: Finnish Medicines Agency
Austria: Federal Ministry for Health and Women
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines

Keywords provided by Bayer:
FC patch
comparator study

ClinicalTrials.gov processed this record on August 28, 2014