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 Endometriosis

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 Endometriosis

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

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