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
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.
Eligibility Criteria
Inclusion
- Women 18 years or older
- With 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 history of endometrial ablation or dilatation or curettage within 2 months prior to study start will be excluded.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00293059
Start Date
December 1 2005
End Date
May 1 2008
Last Update
November 27 2013
Active Locations (46)
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1
Women and Child, LPP
Lake Havasu City, Arizona, United States, 86403
2
Marin Endocrine Associates
Greenbrae, California, United States, 94904
3
Impact Clinical Trials - Los Angeles
Los Angeles, California, United States, 90010
4
Blue Hill Medical Group
Pacific Palisades, California, United States, 90272