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NCT00185289 Clinical Trial

Study to Investigate Efficacy and Safety of a New Oral Contraceptive

Contraception Clinical Trial

Official title:
Multi-center , Open, Uncontrolled Study to Investigate the Efficacy and Safety of a 4 Phasic Oral Contraceptive SH T00658 in a 28-day Regimen for 20 Cycles in Healthy Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00185289
Other study ID # 91191
Secondary ID EudraCT: 2004-00
Status Completed
Phase Phase 3
First received September 10, 2005
Last updated July 14, 2011
Start date April 2004
Est. completion date July 2006

Study information
Verified date July 2011
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and WomenGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 1392
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Healthy volunteers

Exclusion Criteria:

- Any condition that might interfere the outcomes

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• EV/DNG (Qlaira, BAY86-5027, SH T00658K)
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

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

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Germany,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of unintended pregnancies 20 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary Adverse event collection 20 treatment cycles each consisting of 28 days
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