Study to Investigate Efficacy and Safety of a New Oral Contraceptive

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185289
First received: September 10, 2005
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Contraception
Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

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

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

Enrollment: 1392
Study Start Date: April 2004
Study Completion Date: July 2006
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185289

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

Additional Information:
No publications provided

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
Study First Received: September 10, 2005
Last Updated: July 14, 2011
Health Authority: Austria: Federal Ministry for Health and Women
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on April 17, 2014