Status:
COMPLETED
A Long-Term Safety Study 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 long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.
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 long-term safety of asoprisnil 10 mg daily for 6 months, afte...
Eligibility Criteria
Inclusion
- Completed dosing and Day 84 procedures at sites in study M99-144
- No interruption of dosing
- Otherwise continued good health
Exclusion
- Any abnormal lab result the study-doctor considers significant
- History of severe reaction to or current use of hormone therapy
- History of alcohol or drug abuse
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2001
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00156182
Start Date
April 1 2001
End Date
December 1 2001
Last Update
March 4 2009
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