Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of Three Asoprisnil Doses in the Treatment of Women With Endometriosis
Lead Sponsor:
Abbott
Conditions:
Endometriosis
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief Summary
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
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 endometrios...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2001
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00160446
Start Date
May 1 2000
End Date
July 1 2001
Last Update
May 29 2008
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