A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata
18 Years
48 Years
Female
Leiomyoma
Trial Information
A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata
No medical therapy is currently available for the long-term treatment of uterine fibroids.
The objective of this study is to determine the long-term safety of asoprisnil 10 mg daily
for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine
fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will
be based on ultrasound and endometrial biopsy results, adverse events, and any changes from
baseline laboratory values and vital signs.
Inclusion Criteria:
- Completed dosing and Day 84 procedures at sites in study M99-144
- No interruption of dosing
- Otherwise continued good health
Exclusion Criteria:
- Any abnormal lab result the study-doctor considers significant
- History of severe reaction to or current use of hormone therapy
- History of alcohol or drug abuse
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144
Outcome Time Frame:
Treatment months 3 and 6 and Post-treatment months 3 and 6
Safety Issue:
No
Principal Investigator
Medical Director
Investigator Role:
Study Chair
Investigator Affiliation:
Abbott
Authority:
United States: Food and Drug Administration
Study ID:
M01-275
NCT ID:
NCT00156182
Start Date:
April 2001
Completion Date:
December 2001
Related Keywords:
- Leiomyoma
- Fibroid Uterus
- Leiomyoma
- Uterine Fibroids
- asoprisnil
- Leiomyoma
- Myofibroma
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