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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.
Full description
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.
Enrollment
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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:
Subject agrees to double barrier method of contraception
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
130 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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