Status:
COMPLETED
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
Lead Sponsor:
Abbott
Conditions:
Fibroid Uterus
Leiomyoma
Eligibility:
FEMALE
18-53 years
Phase:
PHASE3
Brief Summary
The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal sub...
Detailed Description
No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program...
Eligibility Criteria
Inclusion
- Premenopausal women
- History of regular menstrual cycles (21-42 days)
- Diagnosis of uterine fibroid(s)
- Abnormal vaginal bleeding associated with uterine fibroids
- Otherwise in good health
- Subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small fibroids with a uterine volume of ≥ 200 cm3
Exclusion
- Less than 3 months postpartum and post-lactation
- Previous myomectomy within 1 year
- Any abnormal lab or procedure result the study-doctor considers important
- Severe reaction(s) to or are currently using any hormone therapy
- History of osteoporosis or other bone disease
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT00152256
Start Date
September 1 2003
End Date
February 1 2005
Last Update
May 29 2008
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