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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The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

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 in women and many women must resort to surgery for relief. The objective of this study is to determine the safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.

Official Title
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A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata.

Conditions
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Leiomyoma, Menorrhagia, Metrorrhagia

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 Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails Negative pregnancy test Agrees to Double-barrier method of contraception Pap smear with no evidence of malignancy or pre-malignant changes Endometrial biopsy with no significant histological disorder Exclusion Criteria: 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 Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months History of Polycystic Ovary Syndrome or prolactinoma MRI shows significant gynecologic disorder Uterine size > 25 weeks gestation Hemoglobin < 8 g/dL at Day -1

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>* 10mg Tablet, oral Daily for 12 months<br>|
| Experimental: 2<br> | Drug: Asoprisnil<br>* 25 mg Tablet, oral Daily for 12 months<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Tablet, oral Daily for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention. |  | Month 12 or Final Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention. |  | Month 6 | 
| Change from baseline in menstrual pictogram score. |  | Final Month | 
| Change from baseline in number of days with bleeding. |  | Final Month | 
| Change from baseline in hemoglobin concentration. |  | Final Visit | 
| Percent change from baseline in volume of the largest fibroid. |  | Final Visit | 
| Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms. |  | Final Visit | 
| Change from baseline in total symptom severity score and UFS-QOL total score. |  | Final Visit | 
| Cumulative percent of subjects who achieve amenorrhea. |  | Month 3 | 

 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, asoprisnil