A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
18 Years
N/A
Female
Leiomyoma, Menorrhagia, Metrorrhagia
Trial Information
A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
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 objective of this study is to determine the long-term safety of asoprisnil 10
and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding
associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The
safety endpoints for this study will be based on assessments of the endometrium, ovarian
cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline
laboratory values and vital signs.
Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was
prematurely discontinued for all subjects. To ensure safety, subjects will remain on study
and will undergo scheduled study procedures. In most subjects, endometrial changes
reversed after asoprisnil discontinuation.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Outcome Measure:
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
Outcome Time Frame:
Month 12
Safety Issue:
No
Principal Investigator
Medical Director
Investigator Role:
Study Chair
Investigator Affiliation:
Abbott
Authority:
United States: Food and Drug Administration
Study ID:
M01-391
NCT ID:
NCT00156195
Start Date:
September 2003
Completion Date:
January 2007
Related Keywords:
- Leiomyoma
- Menorrhagia
- Metrorrhagia
- Symptomatic Uterine Fibroids
- Excessive Uterine Bleeding
- Uterine Hemorrhage
- asoprisnil
- Leiomyoma
- Myofibroma
- Menorrhagia
- Metrorrhagia
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