Status:
COMPLETED
Safety of Treatment of Uterine Fibroids With Asoprisnil
Lead Sponsor:
Abbott
Conditions:
Fibroid Uterus
Leiomyoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.
Detailed Description
No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objec...
Eligibility Criteria
Inclusion
- Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment
- Otherwise good health
- Premenopausal based on Estrogen and Follicle Stimulating Hormone levels
- Agrees to double-barrier method of contraception
- Adequate endometrial biopsy with no significant histological disorder
Exclusion
- Any abnormal lab or procedure result(s) the study-doctor considers important
- History of a blood-clotting disorder
- Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away
- Significant gynecological disorder, such as endometrial polyp
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00156208
Start Date
April 1 2004
End Date
December 1 2006
Last Update
May 29 2008
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