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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:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contraception Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K) 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1392 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : April 2004
Actual Study Completion Date : July 2006

Arm Intervention/treatment
Experimental: Arm 1 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

Primary Outcome Measures :
  1. Number of unintended pregnancies [ Time Frame: 20 treatment cycles each consisting of 28 days and follow-up period of 14 days ]

Secondary Outcome Measures :
  1. Adverse event collection [ Time Frame: 20 treatment cycles each consisting of 28 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Any condition that might interfere the outcomes

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 identifier (NCT number): NCT00185289

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Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Therapeutic Area Head, Bayer HealthCare AG Identifier: NCT00185289    
Other Study ID Numbers: 91191
EudraCT: 2004-002098-22
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 15, 2011
Last Verified: July 2011