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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,392
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
Number of unintended pregnancies
Time frame: 20 treatment cycles each consisting of 28 days and follow-up period of 14 days
Adverse event collection
Time frame: 20 treatment cycles each consisting of 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dr. Max Stiglbauer
Wiener Neustadt, Lower Austria, Austria
Praxis Dr. Langer
Fürstenfeld, Styria, Austria
Dr. Meusburger
Wolfurt, Vorarlberg, Austria
Landeskrankenhaus Bregenz
Bregenz, Austria
Dr. Roswitha Wessely
Graz, Austria
Institut für Hormonstörungen und Kinderwunsch
Graz, Austria
Praxis Dr. Gudrun Lorenz-Eberhard
Graz, Austria
Praxis Dr. Hannes Kahr
Graz, Austria
Universitätsklinikum Innsbruck
Innsbruck, Austria
Dr. Peter Mayr
Kufstein, Austria
...and 40 more locations