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

Launched by SOLVAY PHARMACEUTICALS · Oct 25, 2005

Keywords

ClinConnect Summary

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Gender

FEMALE

Eligibility 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