Clinical trial NCT00152256: A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibroid Uterus
Leiomyoma
Menorrhagia
Metrorrhagia
Uterine Fibroids
Keywords: Symptomatic Uterine Fibroids
Excessive Uterine Bleeding
Uterine Hemorrhage
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 239
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative percent of subjects achieving amenorrhea.
timeFrame: Month 3
Secondary outcomes:
measure: Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.
timeFrame: Final Visit
measure: Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.
timeFrame: Final Visit
measure: Change from baseline in the Work Limitation Questionnaire Index.
timeFrame: Final Visit
measure: Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary).
timeFrame: Final Visit
measure: Change from baseline in the monthly bleeding score.
timeFrame: Final Visit
measure: Change from baseline in the hemoglobin concentration.
timeFrame: Final Visit
measure: Change from baseline in volume of the largest fibroid.
timeFrame: Final Visit
measure: Percentage of subjects who discontinue with the intent to have surgery for fibroids during treatment.
timeFrame: During treatment period
measure: Percentage of subjects who respond positively to the global efficacy question.
timeFrame: Final Visit
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Medical Director
role: STUDY_CHAIR
References: