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

Study Timeline

• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-25
• Study First Posted: 2005-10-26
• Study Start: 2005-11
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-28
• Last Update Posted: 2008-03-31

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

Trial Locations

Locations (57)

Site 4007; 🇷🇴 Bucuresti, Romania

Site 4005; 🇷🇴 Bucuresti, Romania

Site 3803; 🇺🇦 Kiev, Ukraine

Site 3802; 🇺🇦 Odessa, Ukraine

Site 3807; 🇺🇦 Kiev, Ukraine

Site 2701; 🇿🇦 Roodepoort, South Africa

Site 0703; 🇷🇺 St. Petersburg, Russian Federation

Site 0704; 🇷🇺 St. Petersburg, Russian Federation

Site 6101; 🇦🇺 Clayton, Australia

Site 6103; 🇦🇺 Nedlands, Australia

Site 6104; 🇦🇺 Randwick, Australia

Site 6102; 🇦🇺 Sydney, Australia

Site 4901; 🇩🇪 Herne, Germany

Site 0701; 🇷🇺 Moscow, Russian Federation

Site 0904; 🇷🇺 Moscow, Russian Federation

Site 3806; 🇺🇦 Kiev, Ukraine

Site 4006; 🇷🇴 Bucuresti, Romania

Site 4003; 🇷🇴 Craiova, Romania

Site 0901; 🇷🇺 Moscow, Russian Federation

Site 0903; 🇷🇺 Moscow, Russian Federation

Site 0705; 🇷🇺 St. Petersburg, Russian Federation

Site 2702; 🇿🇦 Centurion, South Africa

Site 3808; 🇺🇦 Kiev, Ukraine

Site 3504; 🇧🇬 Sofia, Bulgaria

Site 4904; 🇩🇪 Berlin, Germany

Site 4905; 🇩🇪 Dresden, Germany

Site 3501; 🇧🇬 Sofia, Bulgaria

Site 3203; 🇧🇪 Leuven, Belgium

Site 0707; 🇷🇺 St. Petersburg, Russian Federation

Site 2703; 🇿🇦 Cape Town, South Africa

Site 3801; 🇺🇦 Donetsk, Ukraine

Site 2705; 🇿🇦 Bloemfontein, South Africa

Site 3502; 🇧🇬 Sofia, Bulgaria

Site 4902; 🇩🇪 Tuebingen, Germany

Site 3505; 🇧🇬 Sofia, Bulgaria

Site 0902; 🇷🇺 Moscow, Russian Federation

Site 3503; 🇧🇬 Sofia, Bulgaria

Site 3201; 🇧🇪 Aalter, Belgium

Site 3202; 🇧🇪 Brussels, Belgium

Site 3506; 🇧🇬 Sofia, Bulgaria

Site 0905; 🇷🇺 Moscow, Russian Federation

Site 4903; 🇩🇪 Heidelberg, Germany

Site 0906; 🇷🇺 Moscow, Russian Federation

Site 2704; 🇿🇦 Roodepoort, South Africa

Site 0909; 🇷🇺 Moscow, Russian Federation

Site 0702; 🇷🇺 St. Petersburg, Russian Federation

Site 4001; 🇷🇴 Bucuresti, Romania

Site 4004; 🇷🇴 Bucuresti, Romania

Site 4008; 🇷🇴 Constanta, Romania

Site 0907; 🇷🇺 Moscow, Russian Federation

Site 0908; 🇷🇺 Moscow, Russian Federation

Site 4000; 🇷🇴 Bucuresti, Romania

Site 0706; 🇷🇺 St. Petersburg, Russian Federation

Site 3805; 🇺🇦 Dnepropetrovsk, Ukraine

Site 3804; 🇺🇦 Zaporozhye, Ukraine

Site 4002; 🇷🇴 Bucuresti, Romania

Site 4009; 🇷🇴 Bucuresti, Romania