Efficacy and Safety Study of an Oral Contraceptive in Healthy Females

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: NCT00206583
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 1, 2014
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to determine whether the study drug is safe and effective 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 T00658ID) Phase 3

Detailed Description:
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 499 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multicenter, Open-label Uncontrolled Study to Investigate the Efficacy and Safety of a 4-phasic Oral Contraceptive SH T0065 in a 28-day Regimen for 13 Cycles in Healthy Female Subjects
Study Start Date : March 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : July 2007

Arm Intervention/treatment
Experimental: EV/DNG (Qlaira, BAY86-5027)
Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral)
Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral)

Primary Outcome Measures :
  1. Number of unintended pregnancies after 1 year [ Time Frame: Throughout 1 year of treatment ]

Secondary Outcome Measures :
  1. Bleeding pattern and cycle control parameters after 1 year [ Time Frame: Throughout 1 year of treatment ]

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

Inclusion Criteria:

  • Healthy women between the ages of 18 and 35 years requiring contraception

Exclusion Criteria:

  • Pregnancy, lactation, and contraindication of combined oral contraceptive

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): NCT00206583

  Show 29 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00206583     History of Changes
Other Study ID Numbers: 90959
304742 ( Other Identifier: Company internal )
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

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