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Study to Investigate Efficacy and Safety of a New Oral Contraceptive

NCT ID: NCT00185289

Last Updated: 2011-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers

Exclusion Criteria

* Any condition that might interfere the outcomes
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer HealthCare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Dr. Max Stiglbauer

Wiener Neustadt, Lower Austria, Austria

Site Status

Praxis Dr. Langer

Fürstenfeld, Styria, Austria

Site Status

Dr. Meusburger

Wolfurt, Vorarlberg, Austria

Site Status

Landeskrankenhaus Bregenz

Bregenz, , Austria

Site Status

Dr. Roswitha Wessely

Graz, , Austria

Site Status

Institut für Hormonstörungen und Kinderwunsch

Graz, , Austria

Site Status

Praxis Dr. Gudrun Lorenz-Eberhard

Graz, , Austria

Site Status

Praxis Dr. Hannes Kahr

Graz, , Austria

Site Status

Universitätsklinikum Innsbruck

Innsbruck, , Austria

Site Status

Dr. Peter Mayr

Kufstein, , Austria

Site Status

Dr. Michaela Boeckl

Salzburg, , Austria

Site Status

Dr. Sigrid Schmidl-Amann

Sankt Pölten, , Austria

Site Status

Dr. Guenther Heytmanek

Vienna, , Austria

Site Status

Dr. Ewald Boschitsch

Vienna, , Austria

Site Status

Dr. Brigitte Wiesenthal

Vienna, , Austria

Site Status

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Vienna, , Austria

Site Status

Dr. Wolfgang Bartl

Vienna, , Austria

Site Status

Dr. Walter Paulik

Zeltweg, , Austria

Site Status

Praxis Hr. Dr. A. Soder

Ettlingen, Baden-Wurttemberg, Germany

Site Status

Praxis Hr. Dr. U. Kohoutek

Karlsruhe, Baden-Wurttemberg, Germany

Site Status

Praxis Hr. Dr. L. Weihe

Ansbach, Bavaria, Germany

Site Status

Praxis Hr. Dr. D. Rautenberg

Hamburg, City state of Hamburg, Germany

Site Status

Frauenarztpraxis Dr. med. Wolfram Brach

Dietzenbach, Hesse, Germany

Site Status

Praxis Hr. Dr. Werner Göttker-Schnetmann

Frankfurt am Main, Hesse, Germany

Site Status

Praxis Dr. S. El Tobgui-Jensen

Frankfurt am Main, Hesse, Germany

Site Status

Praxis Dr. S. Clauss-Hoffmann

Frankfurt am Main, Hesse, Germany

Site Status

Praxis Hr. Dr. P. Schwaner

Frankfurt am Main, Hesse, Germany

Site Status

Praxis Dr. Kindt

Langen, Hesse, Germany

Site Status

Praxis Fr. Dr. J. Tyagi

Mühlheim am Main, Hesse, Germany

Site Status

Praxis Hr. Dr. H. Zabel

Bovenden, Lower Saxony, Germany

Site Status

Praxis Hr. Dr. K. Brauns

Hamelin, Lower Saxony, Germany

Site Status

Praxis Hr. Dr. K. Greven

Hanover, Lower Saxony, Germany

Site Status

Praxis Hr. Dr. H. Frommeyer

Osnabrück, Lower Saxony, Germany

Site Status

Frauenarztpraxis Dr. Schoenberg

Rheine, North Rhine-Westphalia, Germany

Site Status

Praxis Fr. I. Gröger

Wurzen, Saxony, Germany

Site Status

Praxis Hr. H. Thelen

Jessen, Saxony-Anhalt, Germany

Site Status

Frauenarztpraxis Dr. med. Gabriele Weinreich

Magdeburg, Saxony-Anhalt, Germany

Site Status

Dinox GmbH Berlin

Berlin, State of Berlin, Germany

Site Status

Charité Campus Benjamin Franklin

Berlin, State of Berlin, Germany

Site Status

Frauenarztpraxis Fr. Dr. S. Gramatte

Berlin, State of Berlin, Germany

Site Status

Praxis Fr. Dr. B. Wernecke

Berlin, State of Berlin, Germany

Site Status

Praxis Fr. Dr. I. Hannig

Berlin, State of Berlin, Germany

Site Status

Praxis Fr. Dr. K. Maar

Berlin, State of Berlin, Germany

Site Status

Praxis Hr. Dr. R. Etzrodt

Gera, Thuringia, Germany

Site Status

Frauenarztpraxis Fr. Dr. H. Schlegel

Saalfeld, Thuringia, Germany

Site Status

USP Institut Universitari Dexeus

Barcelona, Barcelona, Spain

Site Status

Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues

Gavà, Barcelona, Spain

Site Status

Hospital Universitario MAterno Infantil de Canarias

Las Palmas, Gran Canaria, Spain

Site Status

Instituto Palacios de Salud y Medicina de la Mujer

Madrid, , Spain

Site Status

Complejo Hospitalario Ntra. Sra. de Valme

Seville, , Spain

Site Status

Countries

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Austria Germany Spain

Other Identifiers

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EudraCT: 2004-002098-22

Identifier Type: -

Identifier Source: secondary_id

306660

Identifier Type: -

Identifier Source: secondary_id

91191

Identifier Type: -

Identifier Source: org_study_id

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