Status:
COMPLETED
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
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00244452
Start Date
November 1 2005
End Date
September 1 2006
Last Update
March 31 2008
Active Locations (57)
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1
Site 6101
Clayton, Australia
2
Site 6103
Nedlands, Australia
3
Site 6104
Randwick, Australia
4
Site 6102
Sydney, Australia