Clinical trial NCT00185289: Study to Investigate Efficacy and Safety of a New Oral Contraceptive
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 1392
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Any condition that might interfere the outcomes

Primary outcomes:
measure: Number of unintended pregnancies
timeFrame: 20 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary outcomes:
measure: Adverse event collection
timeFrame: 20 treatment cycles each consisting of 28 days
Other outcomes:
Locations:
city: Wiener Neustadt
country: Austria
facility: Dr. Max Stiglbauer
state: Niederösterreich
city: Fuerstenfeld
country: Austria
facility: Praxis Dr. Langer
state: Steiermark
city: Wolfurt
country: Austria
facility: Dr. Meusburger
state: Vorarlberg
city: Bregenz
country: Austria
facility: Landeskrankenhaus Bregenz
city: Graz
country: Austria
facility: Dr. Roswitha Wessely
city: Graz
country: Austria
facility: Institut für Hormonstörungen und Kinderwunsch
city: Graz
country: Austria
facility: Praxis Dr. Gudrun Lorenz-Eberhard
city: Graz
country: Austria
facility: Praxis Dr. Hannes Kahr
city: Innsbruck
country: Austria
facility: Universitätsklinikum Innsbruck
city: Kufstein
country: Austria
facility: Dr. Peter Mayr
city: Salzburg
country: Austria
facility: Dr. Michaela Boeckl
city: St. Poelten
country: Austria
facility: Dr. Sigrid Schmidl-Amann
city: Wien
country: Austria
facility: Dr. Guenther Heytmanek
city: Wien
country: Austria
facility: Dr. Ewald Boschitsch
city: Wien
country: Austria
facility: Dr. Brigitte Wiesenthal
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien Universitätskliniken
city: Wien
country: Austria
facility: Dr. Wolfgang Bartl
city: Zeltweg
country: Austria
facility: Dr. Walter Paulik
city: Ettlingen
country: Germany
facility: Praxis Hr. Dr. A. Soder
state: Baden-Württemberg
city: Karlsruhe
country: Germany
facility: Praxis Hr. Dr. U. Kohoutek
state: Baden-Württemberg
city: Ansbach
country: Germany
facility: Praxis Hr. Dr. L. Weihe
state: Bayern
city: Dietzenbach
country: Germany
facility: Frauenarztpraxis Dr. med. Wolfram Brach
state: Hessen
city: Frankfurt
country: Germany
facility: Praxis Hr. Dr. Werner Göttker-Schnetmann
state: Hessen
city: Frankfurt
country: Germany
facility: Praxis Dr. S. El Tobgui-Jensen
state: Hessen
city: Frankfurt
country: Germany
facility: Praxis Dr. S. Clauss-Hoffmann
state: Hessen
city: Frankfurt
country: Germany
facility: Praxis Hr. Dr. P. Schwaner
state: Hessen
city: Langen
country: Germany
facility: Praxis Dr. Kindt
state: Hessen
city: Mühlheim
country: Germany
facility: Praxis Fr. Dr. J. Tyagi
state: Hessen
city: Bovenden
country: Germany
facility: Praxis Hr. Dr. H. Zabel
state: Niedersachsen
city: Hameln
country: Germany
facility: Praxis Hr. Dr. K. Brauns
state: Niedersachsen
city: Hannover
country: Germany
facility: Praxis Hr. Dr. K. Greven
state: Niedersachsen
city: Osnabrück
country: Germany
facility: Praxis Hr. Dr. H. Frommeyer
state: Niedersachsen
city: Rheine
country: Germany
facility: Frauenarztpraxis Dr. Schoenberg
state: Nordrhein-Westfalen
city: Jessen
country: Germany
facility: Praxis Hr. H. Thelen
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Frauenarztpraxis Dr. med. Gabriele Weinreich
state: Sachsen-Anhalt
city: Wurzen
country: Germany
facility: Praxis Fr. I. Gröger
state: Sachsen
city: Gera
country: Germany
facility: Praxis Hr. Dr. R. Etzrodt
state: Thüringen
city: Saalfeld
country: Germany
facility: Frauenarztpraxis Fr. Dr. H. Schlegel
state: Thüringen
city: Berlin
country: Germany
facility: Dinox GmbH Berlin
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Frauenarztpraxis Fr. Dr. S. Gramatte
city: Berlin
country: Germany
facility: Praxis Fr. Dr. B. Wernecke
city: Berlin
country: Germany
facility: Praxis Fr. Dr. I. Hannig
city: Berlin
country: Germany
facility: Praxis Fr. Dr. K. Maar
city: Hamburg
country: Germany
facility: Praxis Hr. Dr. D. Rautenberg
city: Gava
country: Spain
facility: Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues
state: Barcelona
city: Las Palmas
country: Spain
facility: Hospital Universitario MAterno Infantil de Canarias
state: Gran Canaria
city: Barcelona
country: Spain
facility: USP Institut Universitari Dexeus
city: Madrid
country: Spain
facility: Instituto Palacios de Salud y Medicina de la Mujer
city: Sevilla
country: Spain
facility: Complejo Hospitalario Ntra. Sra. de Valme
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: