Efficacy and Safety Study of an Oral Contraceptive in Healthy Females

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: September 30, 2014
Last verified: September 2014
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
Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleeding pattern and cycle control parameters after 1 year [ Time Frame: Throughout 1 year of treatment ] [ Designated as safety issue: No ]

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.

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206583

  Show 29 Study Locations
Sponsors and Collaborators
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 
Study First Received: September 12, 2005
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 24, 2016