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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244452
• Other study ID #: S184.2.101
• Secondary ID: 2004-004739-67
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2005
• Last updated: March 28, 2008
• Start date: November 2005
• Est. completion date: September 2006

Study information

• Verified date: March 2008
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesRussia: Pharmacological Committee, Ministry of HealthRomania: State Institute for Drug ControlBulgaria: Ministry of HealthBelgium: Ministry of Social Affairs, Public Health and the EnvironmentAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Cetrorelix

Locations

Country	Name	City	State
Australia	Site 6101	Clayton
Australia	Site 6103	Nedlands
Australia	Site 6104	Randwick
Australia	Site 6102	Sydney
Belgium	Site 3201	Aalter
Belgium	Site 3202	Brussels
Belgium	Site 3203	Leuven
Bulgaria	Site 3501	Sofia
Bulgaria	Site 3502	Sofia
Bulgaria	Site 3503	Sofia
Bulgaria	Site 3504	Sofia
Bulgaria	Site 3505	Sofia
Bulgaria	Site 3506	Sofia
Germany	Site 4904	Berlin
Germany	Site 4905	Dresden
Germany	Site 4903	Heidelberg
Germany	Site 4901	Herne
Germany	Site 4902	Tuebingen
Romania	Site 4000	Bucuresti
Romania	Site 4001	Bucuresti
Romania	Site 4002	Bucuresti
Romania	Site 4004	Bucuresti
Romania	Site 4005	Bucuresti
Romania	Site 4006	Bucuresti
Romania	Site 4007	Bucuresti
Romania	Site 4009	Bucuresti
Romania	Site 4008	Constanta
Romania	Site 4003	Craiova
Russian Federation	Site 0701	Moscow
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	Site 0907	Moscow
Russian Federation	Site 0908	Moscow
Russian Federation	Site 0909	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
South Africa	Site 2705	Bloemfontein
South Africa	Site 2703	Cape Town
South Africa	Site 2702	Centurion
South Africa	Site 2701	Roodepoort
South Africa	Site 2704	Roodepoort
Ukraine	Site 3805	Dnepropetrovsk
Ukraine	Site 3801	Donetsk
Ukraine	Site 3803	Kiev
Ukraine	Site 3806	Kiev
Ukraine	Site 3807	Kiev
Ukraine	Site 3808	Kiev
Ukraine	Site 3802	Odessa
Ukraine	Site 3804	Zaporozhye

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Belgium,  Bulgaria,  Germany,  Romania,  Russian Federation,  South Africa,  Ukraine,