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. Michaela Boeckl
🇦🇹Salzburg, Austria
Praxis Fr. Dr. J. Tyagi
🇩🇪Mühlheim, Hessen, Germany
Praxis Dr. Langer
🇦🇹Fuerstenfeld, Steiermark, Austria
Dr. Meusburger
🇦🇹Wolfurt, Vorarlberg, Austria
Dr. Max Stiglbauer
🇦🇹Wiener Neustadt, Niederösterreich, Austria
Landeskrankenhaus Bregenz
🇦🇹Bregenz, Austria
Dr. Roswitha Wessely
🇦🇹Graz, Austria
Institut für Hormonstörungen und Kinderwunsch
🇦🇹Graz, Austria
Praxis Dr. Gudrun Lorenz-Eberhard
🇦🇹Graz, Austria
Universitätsklinikum Innsbruck
🇦🇹Innsbruck, Austria
Dr. Peter Mayr
🇦🇹Kufstein, Austria
Praxis Dr. Hannes Kahr
🇦🇹Graz, Austria
Dr. Sigrid Schmidl-Amann
🇦🇹St. Poelten, Austria
Dr. Brigitte Wiesenthal
🇦🇹Wien, Austria
Dr. Guenther Heytmanek
🇦🇹Wien, Austria
Dr. Ewald Boschitsch
🇦🇹Wien, Austria
Dr. Wolfgang Bartl
🇦🇹Wien, Austria
Allgemeines Krankenhaus der Stadt Wien Universitätskliniken
🇦🇹Wien, Austria
Praxis Hr. Dr. A. Soder
🇩🇪Ettlingen, Baden-Württemberg, Germany
Praxis Hr. Dr. U. Kohoutek
🇩🇪Karlsruhe, Baden-Württemberg, Germany
Praxis Dr. S. El Tobgui-Jensen
🇩🇪Frankfurt, Hessen, Germany
Frauenarztpraxis Dr. med. Wolfram Brach
🇩🇪Dietzenbach, Hessen, Germany
Dr. Walter Paulik
🇦🇹Zeltweg, Austria
Praxis Hr. Dr. L. Weihe
🇩🇪Ansbach, Bayern, Germany
Praxis Hr. Dr. Werner Göttker-Schnetmann
🇩🇪Frankfurt, Hessen, Germany
Praxis Hr. Dr. P. Schwaner
🇩🇪Frankfurt, Hessen, Germany
Praxis Dr. S. Clauss-Hoffmann
🇩🇪Frankfurt, Hessen, Germany
Praxis Dr. Kindt
🇩🇪Langen, Hessen, Germany
Frauenarztpraxis Dr. Schoenberg
🇩🇪Rheine, Nordrhein-Westfalen, Germany
Praxis Hr. Dr. K. Brauns
🇩🇪Hameln, Niedersachsen, Germany
Praxis Hr. Dr. H. Frommeyer
🇩🇪Osnabrück, Niedersachsen, Germany
Frauenarztpraxis Dr. med. Gabriele Weinreich
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
Frauenarztpraxis Fr. Dr. H. Schlegel
🇩🇪Saalfeld, Thüringen, Germany
Dinox GmbH Berlin
🇩🇪Berlin, Germany
Charité Campus Benjamin Franklin
🇩🇪Berlin, Germany
Praxis Hr. Dr. D. Rautenberg
🇩🇪Hamburg, Germany
Hospital Universitario MAterno Infantil de Canarias
🇪🇸Las Palmas, Gran Canaria, Spain
Praxis Fr. Dr. B. Wernecke
🇩🇪Berlin, Germany
Praxis Fr. Dr. K. Maar
🇩🇪Berlin, Germany
Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues
🇪🇸Gava, Barcelona, Spain
Praxis Fr. Dr. I. Hannig
🇩🇪Berlin, Germany
Instituto Palacios de Salud y Medicina de la Mujer
🇪🇸Madrid, Spain
USP Institut Universitari Dexeus
🇪🇸Barcelona, Spain
Praxis Hr. Dr. H. Zabel
🇩🇪Bovenden, Niedersachsen, Germany
Praxis Hr. Dr. K. Greven
🇩🇪Hannover, Niedersachsen, Germany
Praxis Hr. H. Thelen
🇩🇪Jessen, Sachsen-Anhalt, Germany
Praxis Hr. Dr. R. Etzrodt
🇩🇪Gera, Thüringen, Germany
Praxis Fr. I. Gröger
🇩🇪Wurzen, Sachsen, Germany
Complejo Hospitalario Ntra. Sra. de Valme
🇪🇸Sevilla, Spain
Frauenarztpraxis Fr. Dr. S. Gramatte
🇩🇪Berlin, Germany