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

Phase 3

Completed

• Conditions: Fibroid Uterus; Leiomyoma; Menorrhagia; Metrorrhagia; Uterine Fibroids
• Interventions: Drug: Placebo; Drug: Asoprisnil

• Registration Number: NCT00152256
• Lead Sponsor: Abbott

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.

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-27
• Last Update Posted: 2008-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 239

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo	-
1	Asoprisnil	-
2	Asoprisnil	-

Primary Outcome Measures

Name	Time	Method
Cumulative percent of subjects achieving amenorrhea.	Month 3

Secondary Outcome Measures

Name	Time	Method
Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.	Final Visit
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 the hemoglobin concentration.	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