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

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00152256

Collaborator

(none)

239

Enrollment

Arms

17.1

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroids	Drug: Asoprisnil Drug: Asoprisnil Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

239 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Feb 1, 2005

Actual Study Completion Date :

Feb 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Asoprisnil Asoprisnil 10 mg Tablet, oral Daily for 6 months Other Names: J867
Experimental: 2	Drug: Asoprisnil Asoprisnil 25mg Tablet, oral Daily for 6 months Other Names: J867
Placebo Comparator: 3	Drug: Placebo Placebo Tablet, oral Daily for 6 months

Arm

Intervention/Treatment

Experimental: 1

Drug: Asoprisnil

Asoprisnil 10 mg Tablet, oral Daily for 6 months

Other Names:

J867

Experimental: 2

Drug: Asoprisnil

Asoprisnil 25mg Tablet, oral Daily for 6 months

Other Names:

J867

Placebo Comparator: 3

Drug: Placebo

Placebo Tablet, oral Daily for 6 months

Outcome Measures

Primary Outcome Measures

Cumulative percent of subjects achieving amenorrhea. [Month 3]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 53 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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