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
NCT ID: NCT00244452
Last Updated: 2008-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2005-11-30
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Cetrorelix
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Solvay Pharmaceuticals
INDUSTRY
Responsible Party
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Solvay Pharmaceuticals
Principal Investigators
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Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
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Site 6101
Clayton, , Australia
Site 6103
Nedlands, , Australia
Site 6104
Randwick, , Australia
Site 6102
Sydney, , Australia
Site 3201
Aalter, , Belgium
Site 3202
Brussels, , Belgium
Site 3203
Leuven, , Belgium
Site 3501
Sofia, , Bulgaria
Site 3502
Sofia, , Bulgaria
Site 3503
Sofia, , Bulgaria
Site 3504
Sofia, , Bulgaria
Site 3505
Sofia, , Bulgaria
Site 3506
Sofia, , Bulgaria
Site 4904
Berlin, , Germany
Site 4905
Dresden, , Germany
Site 4903
Heidelberg, , Germany
Site 4901
Herne, , Germany
Site 4902
Tübingen, , Germany
Site 4000
Bucharest, , Romania
Site 4001
Bucharest, , Romania
Site 4002
Bucharest, , Romania
Site 4004
Bucharest, , Romania
Site 4005
Bucharest, , Romania
Site 4006
Bucharest, , Romania
Site 4007
Bucharest, , Romania
Site 4009
Bucharest, , Romania
Site 4008
Constanța, , Romania
Site 4003
Craiova, , Romania
Site 0701
Moscow, , Russia
Site 0901
Moscow, , Russia
Site 0902
Moscow, , Russia
Site 0903
Moscow, , Russia
Site 0904
Moscow, , Russia
Site 0905
Moscow, , Russia
Site 0906
Moscow, , Russia
Site 0907
Moscow, , Russia
Site 0908
Moscow, , Russia
Site 0909
Moscow, , Russia
Site 0702
Saint Petersburg, , Russia
Site 0703
Saint Petersburg, , Russia
Site 0704
Saint Petersburg, , Russia
Site 0705
Saint Petersburg, , Russia
Site 0706
Saint Petersburg, , Russia
Site 0707
Saint Petersburg, , Russia
Site 2705
Bloemfontein, , South Africa
Site 2703
Cape Town, , South Africa
Site 2702
Centurion, , South Africa
Site 2701
Roodepoort, , South Africa
Site 2704
Roodepoort, , South Africa
Site 3805
Dnipro, , Ukraine
Site 3801
Donetsk, , Ukraine
Site 3803
Kiev, , Ukraine
Site 3806
Kiev, , Ukraine
Site 3807
Kiev, , Ukraine
Site 3808
Kiev, , Ukraine
Site 3802
Odesa, , Ukraine
Site 3804
Zaporizhzhya, , Ukraine
Countries
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Other Identifiers
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2004-004739-67
Identifier Type: -
Identifier Source: secondary_id
S184.2.101
Identifier Type: -
Identifier Source: org_study_id