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Study to Investigate Efficacy and Safety of a New Oral Contraceptive

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ClinicalTrials.gov Identifier: NCT00185289
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 15, 2011
Sponsor:
Information provided by:

Study Description
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.

Study Design

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
Study Completion Date : July 2006
Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Any condition that might interfere the outcomes
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): NCT00185289


  Show 50 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00185289     History of Changes
Other Study ID Numbers: 91191
EudraCT: 2004-002098-22
306660
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 15, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female