Study to Investigate Efficacy and Safety of a New Oral Contraceptive

July 14, 2011 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1392

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Any condition that might interfere the outcomes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of unintended pregnancies
Time Frame: 20 treatment cycles each consisting of 28 days and follow-up period of 14 days
20 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse event collection
Time Frame: 20 treatment cycles each consisting of 28 days
20 treatment cycles each consisting of 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

July 15, 2011

Last Update Submitted That Met QC Criteria

July 14, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 91191
  • EudraCT: 2004-002098-22
  • 306660

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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