Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
Lead Sponsor:
Abbott
Conditions:
Leiomyoma
Eligibility:
FEMALE
18-48 years
Phase:
PHASE2
Brief Summary
This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.
Detailed Description
No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, comp...
Eligibility Criteria
Inclusion
- Women between 18 and 49 years of age
- Diagnosis of either 1 or more uterine fibroids
- History of regular menstrual cycles of 21 to 35 days in length.
Exclusion
- Any abnormal lab result the study-doctor considers significant
- History of severe reaction to or current use of hormone therapy
- History of osteoporosis or other bone disease
- History of uterine artery embolization, cryomyolysis, or electrical myolysis
- Subject currently breast feeding
- Hemoglobin \< 8 g/dL at baseline
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2001
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00160459
Start Date
May 1 2000
End Date
July 1 2001
Last Update
May 29 2008
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