The aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause.
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
TREATMENT
Masking
TRIPLE
Enrollment
26
5mg/day
10mg/day
25mg/day
Individual relative change in uterine bleeding scores by PBAC
Time frame: Pretreatment cycle treatment phase
Endometrial thickness
Time frame: End of treatment
Adverse events collection
Time frame: Whole treatment period
Bleeding pattern
Time frame: Treatment period
Endometrial histology incl. immunohistochemical evaluations
Time frame: End of treatment
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Placebo