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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
130
5mg Tablet, oral Daily for 12 weeks
10 mg Tablet, oral Daily for 12 weeks
25 mg Tablet, oral Daily for 12 weeks
Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary
Time frame: Mean change from baseline to Months 1, 2, 3
Global efficacy question
Time frame: Final visit
Pain (dysmenorrhea, dyspareunia, pelvic pain) pelvic tenderness and induration evaluated during office visits using modified Biberoglu and Behrman grading scale
Time frame: Each monthly visit
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Tablet, oral Daily for 12 weeks