A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
239 participants in 3 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal