Status:
COMPLETED
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
Lead Sponsor:
Abbott
Conditions:
Leiomyoma
Menorrhagia
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 treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
- Otherwise in good health
- Premenopausal based on Estrogen and FSH levels
- Agrees to use of 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
- Significant gynecological disorder such as confirmed endometrial polyp
- Hemoglobin \< 8.0 g/dL
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
523 Patients enrolled
Trial Details
Trial ID
NCT00156195
Start Date
September 1 2003
End Date
January 1 2007
Last Update
May 29 2008
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.