A Long-Term Study to Evaluate the Safety of Asoprisnil in the Treatment of Women With Endometriosis From Study M01-398

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 5 mg for 12 months in women with endometriosis from study M01-398.

Detailed Description
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Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. Although all major endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. The major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. The objective of this study is to determine the long-term safety of asoprisnil 5 mg daily for 12 months in women with endometriosis, after an initial 12 weeks in study M01-398. The safety will be based on assessments of the endometrium, lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

Official Title
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A Phase 2, 12-Month, Open Label Extension Study to Evaluate the Safety of J867(5 mg QD) in Subjects With Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Asoprisnil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed 3 months of dosing and Month 3 procedures in study M01-398 Otherwise in good health Month 3 (M01-398) ultrasound reveals no significant gynecologic disorder Exclusion Criteria: Any abnormal lab or procedure result the study-doctor considers important Anticipated need for excluded hormonal therapy or unapproved narcotics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Asoprisnil<br>* 5mg 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 |
| --- | --- | --- |
| Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale. |  | Months 1,3,6,9,12 and final visit | 
| Change from baseline in pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration assessed by modified Biberoglu and Behrman grading scale. |  | Months 3,6,9,12 and final visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with amenorrhea. |  | Throught treatment period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic pain, Dysmenorrhea, Dyspareunia, Infertility, asoprisnil