Status:
COMPLETED
Study of Asoprisnil in the Treatment of Uterine Fibroids.
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 abnormal uterine bleeding associated with uterine fibroids.
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 who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment
- Otherwise in good health
- Premenopausal based on Estrogen and FSH levels
- Adequate endometrial biopsy with no significant histological disorder
- Agrees to use double-barrier method of contraception
Exclusion
- Any abnormal lab or procedure result(s) the study-doctor considers important
- History of a blood-clotting disorder
- History of osteoporosis requiring treatment
- Any invasive procedure(s) (D\&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study
- Hemoglobin \< 8.0 g/dL
- Endometrial thickness ≥ 19 mm
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT00156156
Start Date
November 1 2004
End Date
February 1 2007
Last Update
May 28 2008
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