A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.
18 Years
48 Years
Female
Leiomyoma
Trial Information
A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy 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 safety and efficacy of asoprisnil 5 mg, 10
mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more
uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites
will be allowed to enter an open-label extension study
Inclusion Criteria:
- Women between 18 and 49 years of age
- Diagnosis of either 1 or more uterine fibroids
- History of regular menstrual cycles of 21 to 35 days in length.
Exclusion Criteria:
- Any abnormal lab result the study-doctor considers significant
- History of severe reaction to or current use of hormone therapy
- History of osteoporosis or other bone disease
- History of uterine artery embolization, cryomyolysis, or electrical myolysis
- Subject currently breast feeding
- Hemoglobin < 8 g/dL at baseline
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Percent change from baseline in uterine volume and volume of the largest fibroid.
Outcome Time Frame:
Treatment weeks 4, 8, 12 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:
M99-144
NCT ID:
NCT00160459
Start Date:
May 2000
Completion Date:
July 2001
Related Keywords:
- Leiomyoma
- Fibroid Uterus
- Leiomyoma
- Uterine Fibroids
- asoprisnil
- Leiomyoma
- Myofibroma
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