Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia, Uterine Fibroids
Conditions
Keywords
Symptomatic Uterine Fibroids, Excessive Uterine Bleeding, Uterine Hemorrhage
Brief summary
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.
Detailed 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.
Interventions
DRUGAsoprisnil
Asoprisnil 10 mg Tablet, oral Daily for 6 months
DRUGPlacebo
Placebo Tablet, oral Daily for 6 months
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 53 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative percent of subjects achieving amenorrhea. | Month 3 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms. | Final Visit |
| Change from baseline in the Work Limitation Questionnaire Index. | Final Visit |
| Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary). | Final Visit |
| Change from baseline in the monthly bleeding score. | Final Visit |
| Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score. | Final Visit |
| Change from baseline in volume of the largest fibroid. | Final Visit |
| Percentage of subjects who discontinue with the intent to have surgery for fibroids during treatment. | During treatment period |
| Percentage of subjects who respond positively to the global efficacy question. | Final Visit |
| Change from baseline in the hemoglobin concentration. | Final Visit |
Outcome results
None listed