A Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed End

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief

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

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Cetrorelix

Criteria

Inclusion Criteria:

• Premenopausal female,

• history of regular menstrual periods,

• any of the symptoms dysmenorrhea,

• dyspareunia or pelvic pain assessed as moderate to severe,

• endometriosis confirmed by histology within 36 months,

• use of barrier contraception throughout the study

Exclusion Criteria:

• Insufficient wash out period for other endometriosis treatments,

• resection or destruction of endometriotic lesions less than 12 weeks prior to screening,

• need for strong opioid analgesics,

• need for immediate surgical treatment of endometriosis,

• any condition that interferes with adherence to study procedures or study assessments