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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00244452
Registration number
NCT00244452
Ethics application status
Date submitted
25/10/2005
Date registered
26/10/2005
Date last updated
31/03/2008
Titles & IDs
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
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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
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Secondary ID [1]
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2004-004739-67
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Secondary ID [2]
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S184.2.101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometriosis
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Condition category
Condition code
Reproductive Health and Childbirth
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Other reproductive health and childbirth disorders
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Reproductive Health and Childbirth
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Menstruation and menopause
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2006
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Site 6101 - Clayton
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Recruitment hospital [2]
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Site 6103 - Nedlands
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Recruitment hospital [3]
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Site 6104 - Randwick
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Recruitment hospital [4]
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Site 6102 - Sydney
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Recruitment postcode(s) [1]
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- Clayton
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Recruitment postcode(s) [2]
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- Nedlands
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Recruitment postcode(s) [3]
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- Randwick
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Recruitment postcode(s) [4]
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- Sydney
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Aalter
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Belgium
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Brussels
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Belgium
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Leuven
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Bulgaria
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Sofia
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Heidelberg
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Germany
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Herne
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Germany
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Tuebingen
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Romania
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Bucuresti
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Romania
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Constanta
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Romania
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Craiova
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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South Africa
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Bloemfontein
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South Africa
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Cape Town
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South Africa
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Centurion
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South Africa
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Roodepoort
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Ukraine
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Dnepropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Kiev
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Ukraine
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Odessa
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Ukraine
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Zaporozhye
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Solvay Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief
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Trial website
https://clinicaltrials.gov/study/NCT00244452
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Global Clinical Director Solvay
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Address
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Solvay Pharmaceuticals
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00244452
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