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
Phase 2
Completed
- Conditions
- Endometriosis
- Registration Number
- NCT00244452
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (57)
Site 6101
🇦🇺Clayton, Australia
Site 6103
🇦🇺Nedlands, Australia
Site 6104
🇦🇺Randwick, Australia
Site 6102
🇦🇺Sydney, Australia
Site 3201
🇧🇪Aalter, Belgium
Site 3202
🇧🇪Brussels, Belgium
Site 3203
🇧🇪Leuven, Belgium
Site 3501
🇧🇬Sofia, Bulgaria
Site 3502
🇧🇬Sofia, Bulgaria
Site 3503
🇧🇬Sofia, Bulgaria
Scroll for more (47 remaining)Site 6101🇦🇺Clayton, Australia