Study to Investigate Efficacy and Safety of a New Oral Contraceptive
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
3 other identifiers
interventional
1,392
3 countries
50
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2004
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedJuly 15, 2011
July 1, 2011
September 10, 2005
July 14, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Number of unintended pregnancies
20 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary Outcomes (1)
Adverse event collection
20 treatment cycles each consisting of 28 days
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Healthy volunteers
You may not qualify if:
- Any condition that might interfere the outcomes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (50)
Dr. Max Stiglbauer
Wiener Neustadt, Lower Austria, 2700, Austria
Praxis Dr. Langer
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, 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
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 10, 2005
First Posted
September 16, 2005
Study Start
April 1, 2004
Study Completion
July 1, 2006
Last Updated
July 15, 2011
Record last verified: 2011-07