FC Patch Comparator Study

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: December 30, 2015
Last verified: December 2015
The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.

Condition Intervention Phase
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 (0.9 mg Ethinylestradiol/1.9 mg Gestodene) vs. a Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin) in 400 Healthy Female Volunteers

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Bleeding pattern and cycle control [ Time Frame: 13 cycles ] [ Designated as safety issue: No ]
  • Number of pregnancies [ Time Frame: 13 cycles ] [ Designated as safety issue: No ]

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

Enrollment: 422
Study Start Date: November 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY86-5016, SH P00331F
Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD)
Active Comparator: Arm 2 Drug: SH P00331N
Drug amount per patch: 0.6 mg EE2 + 6 mg 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.

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

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

Wörgl, Tirol, Austria, 6300
Bregenz, Austria, 6900
Graz, Austria, 8010
Wien, Austria, 1030
Wien, Austria, 1090
Zeltweg, Austria, 8740
Helsinki, Finland, 00100
Helsinki, Finland, 00180
Turku, Finland, 20100
Turku, Finland, 20541
Biarritz, France, 64200
Bordeaux, France, 33000
Compiegne, France, 60200
COMPIEGNE cedex, France, 60204
Maisons lafitte, France, 78600
Montargis, France, 45200
Nancy Cedex, France, 54042
Pantin, France, 93500
Paris, France, 75018
Roanne, France, 42300
Saint Germain En Laye, France, 78100
Toulouse, France, 31500
San Fernando, Cádiz, Spain, 11100
Pontevedra, Galicia, Spain, 36002
Salt, Girona, Spain, 17190
Barcelona, Spain, 08006
Guadalajara, Spain, 19002
Santiago de Compostela, Spain, 15701
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00185354     History of Changes
Other Study ID Numbers: 91402  2004-000821-31  307969 
Study First Received: September 13, 2005
Last Updated: December 30, 2015
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 May 03, 2016