Status:
COMPLETED
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
Lead Sponsor:
Bayer
Conditions:
Metrorrhagia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
Eligibility Criteria
Inclusion
- Women 18 years or older
- And with a diagnosis of dysfunctional uterine bleeding without organic pathology
- And with at least one of the following symptoms: prolonged, frequent or excessive bleeding.
Exclusion
- The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
- Women with a history of endometrial ablation or dilatation and curettage within 2 months prior to study start will be excluded.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT00307801
Start Date
February 1 2006
End Date
May 1 2008
Last Update
December 30 2014
Active Locations (36)
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1
Private Practice Dr. Ian Fraser
Ashfield, New South Wales, Australia, NSW 2131
2
King Edward Memorial Hospital
Subiaco, Western Australia, Australia, 6008
3
Gynekologicka ambulance Vanda Horejsi, MD
České Budějovice, Czechia, 37001
4
Center for Clinical& Basic Research
Pardubice, Czechia, 2667