Study to Investigate Efficacy and Safety of a New Oral Contraceptive
- Conditions
- Contraception
- Interventions
- Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
- Registration Number
- NCT00185289
- Lead Sponsor
- Bayer
- Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of a new 4-phasic preparation in the prevention of pregnancies in a large group of volunteers.
- Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1392
- Healthy volunteers
- Any condition that might interfere the outcomes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 EV/DNG (Qlaira, BAY86-5027, SH T00658K) -
- Primary Outcome Measures
Name Time Method Number of unintended pregnancies 20 treatment cycles each consisting of 28 days and follow-up period of 14 days
- Secondary Outcome Measures
Name Time Method Adverse event collection 20 treatment cycles each consisting of 28 days
Trial Locations
- Locations (50)
Dr. Max Stiglbauer
🇦🇹Wiener Neustadt, Niederösterreich, Austria
Praxis Dr. Langer
🇦🇹Fuerstenfeld, Steiermark, Austria
Dr. Meusburger
🇦🇹Wolfurt, Vorarlberg, Austria
Landeskrankenhaus Bregenz
🇦🇹Bregenz, Austria
Dr. Roswitha Wessely
🇦🇹Graz, Austria
Institut für Hormonstörungen und Kinderwunsch
🇦🇹Graz, Austria
Praxis Dr. Gudrun Lorenz-Eberhard
🇦🇹Graz, Austria
Praxis Dr. Hannes Kahr
🇦🇹Graz, Austria
Universitätsklinikum Innsbruck
🇦🇹Innsbruck, Austria
Dr. Peter Mayr
🇦🇹Kufstein, Austria
Scroll for more (40 remaining)Dr. Max Stiglbauer🇦🇹Wiener Neustadt, Niederösterreich, Austria