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

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to determine the safety and efficacy of 3 asoprisnil doses (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in women with endometriosis.

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

Details

• Lead Sponsor: Abbott
• Collaborator: Jenapharm GmbH & Co. KG

Criteria

Inclusion Criteria:

• Premenopausal women (18-40 years)

• Surgically confirmed endometriosis within 3 years

• History of menstrual cycles between 21 and 35 days

• Moderate or severe pelvic pain OR moderate or severe dysmenorrhea OR moderate or severe pelvic tenderness accompanied by at least mild non-menstrual pelvic pain

• Negative pregnancy test

• Agrees to use double barrier method of contraception

• Pap smear with no evidence of malignancy or pre-malignant changes

• Ultrasound with no significant gynecological disorder.

• Otherwise in good health

Exclusion Criteria:

• Less than 3 months after having a baby or breast-feeding

• Any abnormal lab or procedure result the study-doctor considers important

• Severe reaction(s) to hormone therapy

• Anticipated need for excluded hormonal therapy or unapproved narcotics

• Current use of an IUD

• History or prolactinoma