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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2004-002098-22 | |||
| 306660 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV/DNG (Qlaira, BAY86-5027, SH T00658K) | Drug | per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of unintended pregnancies | 20 treatment cycles each consisting of 28 days and follow-up period of 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event collection | 20 treatment cycles each consisting of 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Max Stiglbauer | Wiener Neustadt | Lower Austria | 2700 | Austria | ||
| Praxis Dr. Langer |
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| Fürstenfeld |
| Styria |
| 8280 |
| Austria |
| Dr. Meusburger | Wolfurt | Vorarlberg | 6922 | Austria |
| Landeskrankenhaus Bregenz | Bregenz | 6900 | Austria |
| Dr. Roswitha Wessely | Graz | 8010 | Austria |
| Institut für Hormonstörungen und Kinderwunsch | Graz | 8010 | Austria |
| Praxis Dr. Gudrun Lorenz-Eberhard | Graz | 8010 | Austria |
| Praxis Dr. Hannes Kahr | Graz | 8010 | Austria |
| Universitätsklinikum Innsbruck | Innsbruck | 6020 | Austria |
| Dr. Peter Mayr | Kufstein | 6330 | Austria |
| Dr. Michaela Boeckl | Salzburg | 5020 | Austria |
| Dr. Sigrid Schmidl-Amann | Sankt Pölten | 3100 | Austria |
| Dr. Guenther Heytmanek | Vienna | 1030 | Austria |
| Dr. Ewald Boschitsch | Vienna | 1060 | Austria |
| Dr. Brigitte Wiesenthal | Vienna | 1070 | Austria |
| Allgemeines Krankenhaus der Stadt Wien Universitätskliniken | Vienna | 1090 | Austria |
| Dr. Wolfgang Bartl | Vienna | 1200 | Austria |
| Dr. Walter Paulik | Zeltweg | 8740 | Austria |
| Praxis Hr. Dr. A. Soder | Ettlingen | Baden-Wurttemberg | 76275 | Germany |
| Praxis Hr. Dr. U. Kohoutek | Karlsruhe | Baden-Wurttemberg | 76199 | Germany |
| Praxis Hr. Dr. L. Weihe | Ansbach | Bavaria | 91522 | Germany |
| Praxis Hr. Dr. D. Rautenberg | Hamburg | Free and Hanseatic City of Hamburg | 21073 | Germany |
| Frauenarztpraxis Dr. med. Wolfram Brach | Dietzenbach | Hesse | 63128 | Germany |
| Praxis Hr. Dr. Werner Göttker-Schnetmann | Frankfurt am Main | Hesse | 60322 | Germany |
| Praxis Dr. S. El Tobgui-Jensen | Frankfurt am Main | Hesse | 60439 | Germany |
| Praxis Dr. S. Clauss-Hoffmann | Frankfurt am Main | Hesse | 65929 | Germany |
| Praxis Hr. Dr. P. Schwaner | Frankfurt am Main | Hesse | 65936 | Germany |
| Praxis Dr. Kindt | Langen | Hesse | 63225 | Germany |
| Praxis Fr. Dr. J. Tyagi | Mühlheim am Main | Hesse | 63165 | Germany |
| Praxis Hr. Dr. H. Zabel | Bovenden | Lower Saxony | 37120 | Germany |
| Praxis Hr. Dr. K. Brauns | Hamelin | Lower Saxony | 31785 | Germany |
| Praxis Hr. Dr. K. Greven | Hanover | Lower Saxony | 30459 | Germany |
| Praxis Hr. Dr. H. Frommeyer | Osnabrück | Lower Saxony | 49074 | Germany |
| Frauenarztpraxis Dr. Schoenberg | Rheine | North Rhine-Westphalia | 48431 | Germany |
| Praxis Fr. I. Gröger | Wurzen | Saxony | 04808 | Germany |
| Praxis Hr. H. Thelen | Jessen | Saxony-Anhalt | 06917 | Germany |
| Frauenarztpraxis Dr. med. Gabriele Weinreich | Magdeburg | Saxony-Anhalt | 39130 | Germany |
| Dinox GmbH Berlin | Berlin | State of Berlin | 10115 | Germany |
| Charité Campus Benjamin Franklin | Berlin | State of Berlin | 12200 | Germany |
| Frauenarztpraxis Fr. Dr. S. Gramatte | Berlin | State of Berlin | 12435 | Germany |
| Praxis Fr. Dr. B. Wernecke | Berlin | State of Berlin | 12435 | Germany |
| Praxis Fr. Dr. I. Hannig | Berlin | State of Berlin | 12435 | Germany |
| Praxis Fr. Dr. K. Maar | Berlin | State of Berlin | 13507 | Germany |
| Praxis Hr. Dr. R. Etzrodt | Gera | Thuringia | 07545 | Germany |
| Frauenarztpraxis Fr. Dr. H. Schlegel | Saalfeld | Thuringia | 07318 | Germany |
| USP Institut Universitari Dexeus | Barcelona | Barcelona | 08028 | Spain |
| Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues | Gavà | Barcelona | 08850 | Spain |
| Hospital Universitario MAterno Infantil de Canarias | Las Palmas | Gran Canaria | 35016 | Spain |
| Instituto Palacios de Salud y Medicina de la Mujer | Madrid | 28009 | Spain |
| Complejo Hospitalario Ntra. Sra. de Valme | Seville | 41014 | Spain |