The purpose of this study is to determine whether the study drug is safe and effective in the prevention of pregnancies in a large group of volunteers.
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
499
GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral)
Number of unintended pregnancies after 1 year
Time frame: Throughout 1 year of treatment
Bleeding pattern and cycle control parameters after 1 year
Time frame: Throughout 1 year of treatment
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