A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy

Study Overview
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Brief Summary
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The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and 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 effects of asoprisnil in uterine fibroid growth suppression. Full thickness biopsies obtained from surgical procedures will allow the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial angiogenesis. Various other exploratory immunohistological and biochemical specimens will be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the myometrium, and in uterine fibroids.

Official Title
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A Phase 2, 12-Week, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of J867 on Uterine Artery Blood Flow and the Morphology of the Endometrium, Myometrium, and Uterine Leiomyomata in Subjects With Uterine Leiomyomata Scheduled for Hysterectomy.

Conditions
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Uterine Fibroids, Leiomyoma

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, at least 18 years of age Diagnosis of uterine fibroid(s), confirmed by ultrasound History of menstrual cycles between 17 and 42 days Otherwise in good health Scheduled for a hysterectomy at the end of the treatment period Negative pregnancy test Agrees to double barrier method of contraception Pap test with no evidence of malignancy or pre-malignant changes Endometrial biopsy with no significant histological disorder Exclusion Criteria: Less than 3 months after having a baby or breast-feeding Any abnormal lab or procedure result the study-doctor considers important Severe reaction(s) to or are currently using any hormone therapy History of cancer or alcohol or drug abuse Diagnosis of Polycystic Ovary Syndrome History of prolactinoma Current use of Intrauterine Device Significant gynecological disorder Uterine size > 32 weeks gestation Current diagnosis of endometriosis Uterine artery embolization within 6 months

Ages Eligible for Study
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Minimum Age: 18 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 10mg Tablet, oral Daily for 12 weeks<br>* Other names: J867;|
| Experimental: 2<br> | Drug: Asoprisnil<br>* Asoprisnil 25 mg Tablet, oral Daily for 12 weeks<br>* Other names: J867;|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Placebo 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 |
| --- | --- | --- |
| Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index. |  | Final visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index. |  | Final Visit | 
| Morphological changes in the endometrium, myometrium and uterine fibroids. |  | Final Visit | 
| Change from baseline in menstrual pictogram score. |  | Final Month | 
| Percent change from baseline in volume of the largest fibroid. |  | Final Visit | 
| Endometrial thickness (post-treatment histologic evaluation). |  | Final Visit | 
| Change from baseline in endometrial thickness by transvaginal ultrasound. |  | Final Visit | 
| Percent of ovulatory subjects. |  | Final Month | 
| Change from baseline in the Uterine Fibroid Symptom-Quality of Life total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score. |  | 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, Hysterectomy, Asoprisnil