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FC Patch Comparator Study

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ClinicalTrials.gov Identifier: NCT00185354
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Contraception Drug: BAY86-5016, SH P00331F Drug: SH P00331N Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2004
Primary Completion Date : April 2006
Study Completion Date : April 2006
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  1. Adverse events collection [ Time Frame: 13 cycles ]
  2. Endometrial biopsy [ Time Frame: 13 cycles ]
  3. Physical and gynecological exam [ Time Frame: 13 cycles ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185354


Locations
Austria
Wörgl, Tirol, Austria, 6300
Bregenz, Austria, 6900
Graz, Austria, 8010
Wien, Austria, 1030
Wien, Austria, 1090
Zeltweg, Austria, 8740
Finland
Helsinki, Finland, 00100
Helsinki, Finland, 00180
Turku, Finland, 20100
Turku, Finland, 20541
France
Biarritz, France, 64200
Bordeaux, France, 33000
COMPIEGNE cedex, France, 60204
Compiegne, France, 60200
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
Spain
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
Bayer
Investigators
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 ( EudraCT Number )
307969 ( Other Identifier: Study Number )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015

Keywords provided by Bayer:
FC patch
comparator study

Additional relevant MeSH terms:
Ethinyl Estradiol
Gestodene
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Progestins