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

Condition	Intervention	Phase
Endometriosis	Drug: Cetrorelix	Phase II

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Female

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 througout 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00244452

Gereon Raddatz       gereon.raddatz@solvay.com

Australia
      Site 6101, Clayton,  Australia
      Site 6102, Sydney,  Australia
      Site 6103, Nedlands,  Australia
      Site 6104, Randwick,  Australia
Belgium
      Site 3201, Aalter,  Belgium
      Site 3202, Brussels,  Belgium
      Site 3203, Leuven,  Belgium
Bulgaria
      Site 3501, Sofia,  Bulgaria
      Site 3502, Sofia,  Bulgaria
      Site 3503, Sofia,  Bulgaria
      Site 3504, Sofia,  Bulgaria
      Site 3505, Sofia,  Bulgaria
      Site 3506, Sofia,  Bulgaria
Germany
      Site 4901, Herne,  Germany
      Site 4902, Tuebingen,  Germany
      Site 4903, Heidelberg,  Germany
      Site 4904, Berlin,  Germany
      Site 4905, Dresden,  Germany
Romania
      Site 4001, Bucuresti,  Romania
      Site 4002, Bucuresti,  Romania
      Site 4003, Craiova,  Romania
      Site 4004, Bucuresti,  Romania
      Site 4005, Bucuresti,  Romania
      Site 4006, Bucuresti,  Romania
      Site 4007, Bucuresti,  Romania
      Site 4008, Constanta,  Romania
      Site 4009, Bucuresti,  Romania
      Site 4000, Bucuresti,  Romania
Russian Federation
      Site 0701, Moscow,  Russian Federation
      Site 0702, St Petersburg,  Russian Federation
      Site 0703, St Petersburg,  Russian Federation
      Site 0704, St Petersburg,  Russian Federation
      Site 0705, St Petersburg,  Russian Federation
      Site 0706, St Petersburg,  Russian Federation
      Site 0707, St Petersburg,  Russian Federation
      Site 0901, Moscow,  Russian Federation
      Site 0902, Moscow,  Russian Federation
      Site 0903, Moscow,  Russian Federation
      Site 0904, Moscow,  Russian Federation
      Site 0905, Moscow,  Russian Federation
      Site 0906, Moscow,  Russian Federation

Study chairs or principal investigators

Global Clinical Director Solvay,  Study Director,  Solvay Pharmaceuticals   

Study ID Numbers:  S184.2.101; 2004-004739-67
Last Updated:  December 8, 2005
Record first received:  October 25, 2005
ClinicalTrials.gov Identifier:  NCT00244452
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices; Russia: Pharmacological Committee, Ministry of Health; Romania: State Institute for Drug Control; Bulgaria: Ministry of Health; Belgium: Ministry of Social Affairs, Public Health and the Environment; Australia: National Health and Medical Research Council
ClinicalTrials.gov processed this record on 2006-01-10