Efficacy and Safety Study of an Oral Contraceptive in Healthy Females
- 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
- Healthy women between the ages of 18 and 35 years requiring contraception
- 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)
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
Scroll for more (19 remaining)Women and Children's Hospital, Los Angeles🇺🇸Los Angeles, California, United States