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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Menorrhagia, Fibroid Uterus, Leiomyoma, Metrorrhagia, Uterine Fibroids

Intervention / Treatment
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* Drug: Asoprisnil
* Drug: Asoprisnil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 53 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Asoprisnil<br>* Asoprisnil 10 mg Tablet, oral Daily for 6 months<br>* Other names: J867;|
| Experimental: 2<br> | Drug: Asoprisnil<br>* Asoprisnil 25mg Tablet, oral Daily for 6 months<br>* Other names: J867;|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Placebo Tablet, oral Daily for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative percent of subjects achieving amenorrhea. |  | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptomatic Uterine Fibroids, Excessive Uterine Bleeding, Uterine Hemorrhage