Study to Investigate Efficacy and Safety of a New Oral Contraceptive

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00185289
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 15, 2011
Information provided by:

September 10, 2005
September 16, 2005
July 15, 2011
April 2004
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Number of unintended pregnancies [ Time Frame: 20 treatment cycles each consisting of 28 days and follow-up period of 14 days ]
Number of unintended pregnancies
Complete list of historical versions of study NCT00185289 on Archive Site
Adverse event collection [ Time Frame: 20 treatment cycles each consisting of 28 days ]
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Study to Investigate Efficacy and Safety of a New Oral Contraceptive
Multi-center , Open, Uncontrolled Study to Investigate the Efficacy and Safety of a 4 Phasic Oral Contraceptive SH T00658 in a 28-day Regimen for 20 Cycles in Healthy Female Volunteers
The purpose of this study is to evaluate the safety and effectiveness of a new 4-phasic preparation in the prevention of pregnancies in a large group of volunteers.
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.
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo
Experimental: Arm 1
Intervention: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2006
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Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Any condition that might interfere the outcomes
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Spain
EudraCT: 2004-002098-22
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Therapeutic Area Head, Bayer HealthCare AG
Not Provided
Study Director: Bayer Study Director Bayer
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP