A Study to Evaluate the Safety and Effectiveness of Three Asoprisnil Doses in the Treatment of Women With Endometriosis

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 three doses of asoprisnil, compared to placebo, in the treatment of women with endometriosis.

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 safety and efficacy of asoprisnil 5, 10, and 25 mg tablets, compared to placebo, administered daily for 12 weeks to women with endometriosis, by assessing whether asoprisnil administration diminishes the pelvic pain, dysmenorrhea, dyspareunia, excessive bleeding, and analgesic use associated with this disease and lessens the subjects' perceived pain symptoms. Otherwise healthy women with surgically confirmed endometriosis will be enrolled.

Official Title
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A Phase II Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of J867 Administered in Patients With Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Asoprisnil
* Drug: Asoprisnil
* Drug: Asoprisnil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgically confirmed endometriosis History of menstrual cycles between 26 and 32 days Otherwise in good health Age 18-40 years, inclusive Subject had pain graded at Screening and Day 1 according to a scale suggested by Biberoglu and Berhman5 in at least one of the following categories: moderate or severe pelvic pain not related to menstruation, OR moderate or severe dysmenorrhea, OR moderate or severe pelvic tenderness elicited on pelvic examination accompanied by non-menstrual pelvic pain. Subject agrees to double barrier method of contraception Exclusion Criteria: Any abnormal lab or procedure result the study-doctor considers important History of undiagnosed uterine bleeding or gynecological disorder Severe reaction(s) to hormone therapy History of osteoporosis or other metabolic bone disease Subject currently breast feeding

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Asoprisnil<br>* 5mg Tablet, oral Daily for 12 weeks<br>|
| Experimental: 2<br> | Drug: Asoprisnil<br>* 10 mg Tablet, oral Daily for 12 weeks<br>|
| Experimental: 3<br> | Drug: Asoprisnil<br>* 25 mg Tablet, oral Daily for 12 weeks<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* 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 |
| --- | --- | --- |
| Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary |  | Mean change from baseline to Months 1, 2, 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global efficacy question |  | Final visit | 
| Pain (dysmenorrhea, dyspareunia, pelvic pain) pelvic tenderness and induration evaluated during office visits using modified Biberoglu and Behrman grading scale |  | Each monthly visit | 

 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