Trial Information
A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata
No medical therapy is currently available for the long-term treatment of abnormal uterine
bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated
in a Phase 3 program to establish long term safety and effectiveness and therefore provide
women with a medical alternative to surgery.
Inclusion Criteria:
- Premenopausal women
- History of regular menstrual cycles (21-42 days)
- Diagnosis of uterine fibroid(s)
- Abnormal vaginal bleeding associated with uterine fibroids
- Otherwise in good health
- Subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small
fibroids with a uterine volume of ≥ 200 cm3
Exclusion Criteria:
- Less than 3 months postpartum and post-lactation
- Previous myomectomy within 1 year
- Any abnormal lab or procedure result the study-doctor considers important
- Severe reaction(s) to or are currently using any hormone therapy
- History of osteoporosis or other bone disease
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:
Cumulative percent of subjects achieving amenorrhea.
Outcome Time Frame:
Month 3
Safety Issue:
No
Principal Investigator
Medical Director
Investigator Role:
Study Chair
Investigator Affiliation:
Abbott
Authority:
United States: Food and Drug Administration
Study ID:
C02-037
NCT ID:
NCT00152256
Start Date:
September 2003
Completion Date:
February 2005
Related Keywords:
- Fibroid Uterus
- Leiomyoma
- Menorrhagia
- Metrorrhagia
- Uterine Fibroids
- Symptomatic Uterine Fibroids
- Excessive Uterine Bleeding
- Uterine Hemorrhage
- Leiomyoma
- Myofibroma
- Menorrhagia
- Metrorrhagia