Efficacy and Safety Study of an Oral Contraceptive in Healthy Females

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)

• Registration Number: NCT00206583
• Lead Sponsor: Bayer

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.

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 Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-21
• Primary Completion: 2007-06
• Study Completion: 2007-07
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-30
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 499

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy, lactation, and contraindication of combined oral contraceptive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EV/DNG (Qlaira, BAY86-5027)	EV/DNG (Qlaira, BAY86-5027, SH T00658ID)	Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral)

Primary Outcome Measures

Name	Time	Method
Number of unintended pregnancies after 1 year	Throughout 1 year of treatment

Secondary Outcome Measures

Name	Time	Method
Bleeding pattern and cycle control parameters after 1 year	Throughout 1 year of treatment

Trial Locations

Locations (29)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States

University of Pittsburgh Medical Center Health System; 🇺🇸 Pittsburgh, Pennsylvania, United States

Diex Recherche Inc.; 🇨🇦 Sherbrooke, Quebec, Canada

Women's Care Source; 🇺🇸 Morristown, New Jersey, United States

Visions Clinical Research; 🇺🇸 Palm Springs, Florida, United States

Temple Green Clinic; 🇨🇦 Waterloo, Ontario, Canada

Rhodin Recherche Clinique; 🇨🇦 Drummondville, Quebec, Canada

Comprehensive Clinical Trials; 🇺🇸 West Palm Beach, Florida, United States

Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, United States

Clinique de Gynecologie; 🇨🇦 Shawinigan, Quebec, Canada

Harbor - UCLA Medical Center; 🇺🇸 Torrance, California, United States

Women's Clinic of Lincoln, PC; 🇺🇸 Lincoln, Nebraska, United States

OB/GYN Health Center; 🇺🇸 Medford, Oregon, United States

Clinical Research of Philadelphia, LLC; 🇺🇸 Philadelphia, Pennsylvania, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

Women and Children's Hospital, Los Angeles; 🇺🇸 Los Angeles, California, United States

Lifespan Research; 🇺🇸 Palo Alto, California, United States

Genesis Center for Clinical Research; 🇺🇸 San Diego, California, United States

Clinical Trial Center of Colorado; 🇺🇸 Castle Rock, Colorado, United States

Insignia Care for Women, P.A.; 🇺🇸 Tampa, Florida, United States

New Age Medical Research Corp.; 🇺🇸 Miami, Florida, United States

Physicians Research Group; 🇺🇸 Indianapolis, Indiana, United States

Seattle Women's: Health, Research, Gynecology; 🇺🇸 Seattle, Washington, United States

Total Concept Health Care Inc.; 🇨🇦 Kitchener, Ontario, Canada

Centre d'étude clinique de Montréal Inc.; 🇨🇦 Montreal, Quebec, Canada

Les Gynecologues Associes; 🇨🇦 Montreal, Quebec, Canada

Clinique Recherche en Sante des Femmes Inc.; 🇨🇦 Quebec, Canada

Clinique Médicale des Campus; 🇨🇦 Ste-Foy, Quebec, Canada