Safety of Treatment of Uterine Fibroids With Asoprisnil

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 symptomatic uterine fibroids who completed the 6 month Study C02-037.

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 administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations. 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 III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

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

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 that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment Otherwise good health Premenopausal based on Estrogen and Follicle Stimulating Hormone levels Agrees to 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 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 Significant gynecological disorder, such as endometrial polyp

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>* 10mg Tablet, oral Daily for 18 months<br>* Other names: J867;|
| Experimental: 2<br> | Drug: Asoprisnil<br>* 25 mg Tablet, oral Daily for 18 months<br>* Other names: J867;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long Term Safety |  | Throughout 18 month treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative and incremental amenorrhea rates. |  | Each month 1-18 | 
| Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-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 Uterine Fibroid Impact Questionnaire. |  | Months 6, 12, 18 | 
| Change from baseline in the Work Limitation Questionnaire Index. |  | Final Visit | 
| Change from baseline in the two dimensions of the SF-36. |  | Final Visit | 
| Change from baseline in the monthly bleeding score. |  | Final Month | 
| Change from baseline in the hemoglobin concentration. |  | Final Visit | 
| Percent 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 Period | 
| Percentage of subjects who responded positively to the Global Efficacy Questions. |  | Months 6, 12, 18 | 

 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