A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids

Abbott239 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

239

Conditions

Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroids

Interventions

AsoprisnilDRUG

Asoprisnil 10 mg Tablet, oral Daily for 6 months

AsoprisnilDRUG

Asoprisnil 25mg Tablet, oral Daily for 6 months

PlaceboDRUG

Placebo Tablet, oral Daily for 6 months

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 53 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cumulative percent of subjects achieving amenorrhea.

Time frame: Month 3

Secondary Outcomes

Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.

Time frame: Final Visit

Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.

Time frame: Final Visit

Change from baseline in the Work Limitation Questionnaire Index.

Time frame: Final Visit

Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary).

Time frame: Final Visit

Change from baseline in the monthly bleeding score.

Time frame: Final Visit

Change from baseline in the hemoglobin concentration.

Time frame: Final Visit

Change from baseline in volume of the largest fibroid.

Time frame: Final Visit

Percentage of subjects who discontinue with the intent to have surgery for fibroids during treatment.

Time frame: During treatment period

Percentage of subjects who respond positively to the global efficacy question.

Time frame: Final Visit

Data from ClinicalTrials.gov

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