We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety Study of an Oral Contraceptive in Healthy Females

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00206583
First Posted: September 21, 2005
Last Update Posted: October 1, 2014
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.
Information provided by (Responsible Party):
Bayer
  Purpose
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 Intervention Phase
Contraception Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID) Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Bayer:

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

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

Enrollment: 499
Study Start Date: March 2005
Study Completion Date: July 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

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.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy, lactation, and contraindication of combined oral contraceptive
  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): NCT00206583


  Show 29 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00206583     History of Changes
Other Study ID Numbers: 90959
304742 ( Other Identifier: Company internal )
First Submitted: September 12, 2005
First Posted: September 21, 2005
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