Study to Evaluate the Safety 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 long-term safety of asoprisnil in 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 long-term safety of asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs. Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Official Title
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A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

Conditions
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Leiomyoma, Menorrhagia, Metrorrhagia

Intervention / Treatment
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* Drug: Asoprisnil
* Drug: Asoprisnil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively Otherwise in good health Premenopausal based on Estrogen and FSH levels Agrees to use of double barrier method of contraception Adequate endometrial biopsy with no significant histological disorder Exclusion Criteria: Any abnormal lab or procedure result(s) the study-doctor considers important Significant gynecological disorder such as confirmed endometrial polyp Hemoglobin < 8.0 g/dL History of a blood-clotting disorder Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away.

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Asoprisnil<br>* 10 mg Tablet, oral Daily for 12 months<br>|
| Experimental: 2<br> | Drug: Asoprisnil<br>* 25 mg 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 do not require surgical/invasive intervention. |  | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention. |  | Month 6 | 
| Change from baseline in menstrual pictogram bleeding score. |  | Final Month | 
| Change from baseline in the number of days with bleeding. |  | Final Month | 
| Change from baseline in hemoglobin concentration. |  | Final Visit | 
| Percent change from baseline in the 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 the Uterine Fibroid Symptom-Quality of Life total score. |  | Final Visit | 
| Cumulative percent of subjects who achieve amenorrhea. |  | Each Month | 

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