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Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00244452
Date of registration:	25/10/2005
Prospective Registration:	Yes
Primary sponsor:	Solvay Pharmaceuticals
Public 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
Scientific 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
Date of first enrolment:	November 2005
Target sample size:
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00244452
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Phase:	Phase 2

Countries of recruitment
Australia	Belgium	Bulgaria	Germany	Romania	Russian Federation	South Africa	Ukraine

Contacts

Name:	Global Clinical Director Solvay
Address:
Telephone:
Email:
Affiliation:	Solvay Pharmaceuticals

Key inclusion & exclusion 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 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

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Endometriosis

Intervention(s)

Drug: Cetrorelix

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

2004-004739-67

S184.2.101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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