A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

Study Overview
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Brief Summary
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This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.

Detailed Description
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No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study

Official Title
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A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.

Conditions
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Leiomyoma

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between 18 and 49 years of age Diagnosis of either 1 or more uterine fibroids History of regular menstrual cycles of 21 to 35 days in length. Exclusion Criteria: Any abnormal lab result the study-doctor considers significant History of severe reaction to or current use of hormone therapy History of osteoporosis or other bone disease History of uterine artery embolization, cryomyolysis, or electrical myolysis Subject currently breast feeding Hemoglobin < 8 g/dL at baseline

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 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>* 5 mg Tablet, oral Daily for 12 weeks<br>|
| Experimental: 2<br> | Drug: Asoprisnil<br>* 10 mg Tablet, oral Daily for 12 weeks<br>|
| Experimental: 3<br> | Drug: Asoprisnil<br>* 25 mg Tablet, oral Daily for 12 weeks<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* Tablet, oral Daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in uterine volume and volume of the largest fibroid. |  | Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6. | 
| Duration of amenorrhea |  | Day 1 to 1st post treatment menses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in uterine size in gestational weeks. |  | Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6 | 
| Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume. |  | Week 12 and final visit | 
| Percentage of days with bleeding. |  | Day 1 through end of 1st post-treatment menses | 
| Changes in hematologic and iron parameters. |  | Baseline to each visit | 
| Uterine fibroid symptom improvement. |  | Baseline to each visit | 
| Response to Global Efficacy Question regarding improvement in fibroid symptoms. |  | Week 12 and Final Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibroid Uterus, Leiomyoma, Uterine Fibroids, asoprisnil