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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.

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
GroupInterventionDescription
EV/DNG (Qlaira, BAY86-5027)EV/DNG (Qlaira, BAY86-5027, SH T00658ID)Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral)
Primary Outcome Measures
NameTimeMethod
Number of unintended pregnancies after 1 yearThroughout 1 year of treatment
Secondary Outcome Measures
NameTimeMethod
Bleeding pattern and cycle control parameters after 1 yearThroughout 1 year of treatment

Trial Locations

Locations (29)

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

Medical Center for Clinical Research

🇺🇸

San Diego, California, United States

Harbor - UCLA Medical Center

🇺🇸

Torrance, California, United States

Clinical Trial Center of Colorado

🇺🇸

Castle Rock, Colorado, United States

New Age Medical Research Corp.

🇺🇸

Miami, Florida, United States

Visions Clinical Research

🇺🇸

Palm Springs, Florida, United States

Insignia Care for Women, P.A.

🇺🇸

Tampa, Florida, United States

Comprehensive Clinical Trials

🇺🇸

West Palm Beach, Florida, United States

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