Study Completed

Contraception

Bayer Identifier:

91191

ClinicalTrials.gov Identifier:

NCT00185289

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study to investigate efficacy and safety of a new oral contraceptive

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - 50 Years

Trial summary

Enrollment Goal

1392

Trial Dates

April 2004 - July 2006

Phase

Phase 3

Could I Receive a placebo

Products

Natazia/Qlaira (EV/DNG, BAY86-5027)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Praxis Hr. Dr. U. Kohoutek	Karlsruhe, 76199, Germany
Completed	Praxis Hr. Dr. A. Soder	Ettlingen, 76275, Germany
Completed	Praxis Hr. Dr. L. Weihe	Ansbach, 91522, Germany
Completed	Charité Campus Benjamin Franklin	Berlin, 12200, Germany
Completed	Frauenarztpraxis Fr. Dr. S. Gramatte	Berlin, 12435, Germany
Completed	Praxis Fr. Dr. I. Hannig	Berlin, 12435, Germany
Completed	Dinox GmbH Berlin	Berlin, 10115, Germany
Completed	Praxis Fr. Dr. K. Maar	Berlin, 13507, Germany
Completed	Praxis Fr. Dr. B. Wernecke	Berlin, 12435, Germany
Completed	Praxis Hr. Dr. D. Rautenberg	Hamburg, 21073, Germany
Completed	Frauenarztpraxis Dr. med. Wolfram Brach	Dietzenbach, 63128, Germany
Completed	Praxis Dr. S. Clauss-Hoffmann	Frankfurt, 65929, Germany
Completed	Praxis Dr. S. El Tobgui-Jensen	Frankfurt, 60439, Germany
Completed	Praxis Hr. Dr. H. Frommeyer	Osnabrück, 49074, Germany
Completed	Praxis Hr. Dr. Werner Göttker-Schnetmann	Frankfurt, 60322, Germany
Completed	Praxis Dr. Kindt	Langen, 63225, Germany
Completed	Praxis Hr. Dr. P. Schwaner	Frankfurt, 65936, Germany
Completed	Praxis Fr. Dr. J. Tyagi	Mühlheim, 63165, Germany
Completed	Praxis Hr. Dr. K. Brauns	Hameln, 31785, Germany
Completed	Praxis Hr. Dr. K. Greven	Hannover, 30459, Germany
Completed	Praxis Hr. Dr. H. Zabel	Bovenden, 37120, Germany
Completed	Frauenarztpraxis Dr. Schoenberg	Rheine, 48431, Germany
Completed	Praxis Fr. I. Gröger	Wurzen, 04808, Germany
Completed	Praxis Hr. H. Thelen	Jessen, 06917, Germany
Completed	Frauenarztpraxis Dr. med. Gabriele Weinreich	Magdeburg, 39130, Germany
Completed	Praxis Hr. Dr. R. Etzrodt	Gera, 07545, Germany
Completed	Frauenarztpraxis Fr. Dr. H. Schlegel	Saalfeld, 07318, Germany
Completed	Dr. Sigrid Schmidl-Amann	St. Poelten, 3100, Austria
Completed	Dr. Max Stiglbauer	Wiener Neustadt, 2700, Austria
Completed	Dr. Michaela Boeckl	Salzburg, 5020, Austria
Completed	Praxis Dr. Gudrun Lorenz-Eberhard	Graz, 8010, Austria
Completed	Praxis Dr. Hannes Kahr	Graz, 8010, Austria
Completed	Praxis Dr. Langer	Fuerstenfeld, 8280, Austria
Completed	Dr. Walter Paulik	Zeltweg, 8740, Austria
Completed	Institut für Hormonstörungen und Kinderwunsch	Graz, 8010, Austria
Completed	Dr. Roswitha Wessely	Graz, 8010, Austria
Completed	Dr. Peter Mayr	Kufstein, 6330, Austria
Completed	Universitätsklinikum Innsbruck	Innsbruck, 6020, Austria
Completed	Landeskrankenhaus Bregenz	Bregenz, 6900, Austria
Completed	Dr. Meusburger	Wolfurt, 6922, Austria
Completed	Dr. Wolfgang Bartl	Wien, 1200, Austria
Completed	Dr. Ewald Boschitsch	Wien, 1060, Austria
Completed	Dr. Guenther Heytmanek	Wien, 1030, Austria
Completed	Allgemeines Krankenhaus der Stadt Wien Universitätskliniken	Wien, 1090, Austria
Completed	Dr. Brigitte Wiesenthal	Wien, 1070, Austria
Completed	Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues	Gava, 08850, Spain
Completed	USP Institut Universitari Dexeus	Barcelona, 08028, Spain
Completed	Hospital Universitario MAterno Infantil de Canarias	Las Palmas, 35016, Spain
Completed	Instituto Palacios de Salud y Medicina de la Mujer	Madrid, 28009, Spain
Completed	Complejo Hospitalario Ntra. Sra. de Valme	Sevilla, 41014, Spain

Primary Outcome

Number of unintended pregnancies
Time Frame:
20 treatment cycles each consisting of 28 days and follow-up period of 14 days
Safety Issue:
None

Secondary Outcome

Adverse event collection
Time Frame:
20 treatment cycles each consisting of 28 days
Safety Issue:
None

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Prevention

Allocation

Randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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