Uterine Fibroids Clinical Trial
Official title:
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
Verified date | May 2008 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 239 |
Est. completion date | February 2005 |
Est. primary completion date | February 2005 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 53 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abbott |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative percent of subjects achieving amenorrhea. | Month 3 | No | |
Secondary | Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score. | Final Visit | No | |
Secondary | Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms. | Final Visit | No | |
Secondary | Change from baseline in the Work Limitation Questionnaire Index. | Final Visit | No | |
Secondary | Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary). | Final Visit | No | |
Secondary | Change from baseline in the monthly bleeding score. | Final Visit | No | |
Secondary | Change from baseline in the hemoglobin concentration. | Final Visit | No | |
Secondary | Change from baseline in volume of the largest fibroid. | Final Visit | No | |
Secondary | Percentage of subjects who discontinue with the intent to have surgery for fibroids during treatment. | During treatment period | No | |
Secondary | Percentage of subjects who respond positively to the global efficacy question. | Final Visit | No |
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