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

• Status: Completed
• Trial end date: 2001-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott

Criteria

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:

1. moderate or severe pelvic pain not related to menstruation, OR

2. moderate or severe dysmenorrhea, OR

3. 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