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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-09-30

Brief Summary

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

Detailed Description

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Conditions

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Endometriosis

Keywords

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Endometriosis Cetrorelix Hormone Symptoms relief Safety Tolerability Pharmacodynamic Pharmacokinetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Cetrorelix

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

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

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Site 6103

Nedlands, , Australia

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Site 6104

Randwick, , Australia

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Site 6102

Sydney, , Australia

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Site 3201

Aalter, , Belgium

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Site 3202

Brussels, , Belgium

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Site 3203

Leuven, , Belgium

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Site 3501

Sofia, , Bulgaria

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Site 3502

Sofia, , Bulgaria

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Site 3503

Sofia, , Bulgaria

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Site 3504

Sofia, , Bulgaria

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Site 3505

Sofia, , Bulgaria

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Site 3506

Sofia, , Bulgaria

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Site 4904

Berlin, , Germany

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Site 4905

Dresden, , Germany

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Site 4903

Heidelberg, , Germany

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Site 4901

Herne, , Germany

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Site 4902

Tübingen, , Germany

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Site 4000

Bucharest, , Romania

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Site 4001

Bucharest, , Romania

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Site 4002

Bucharest, , Romania

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Site 4004

Bucharest, , Romania

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Site 4005

Bucharest, , Romania

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Site 4006

Bucharest, , Romania

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Site 4007

Bucharest, , Romania

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Site 4009

Bucharest, , Romania

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Site 4008

Constanța, , Romania

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Site 4003

Craiova, , Romania

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Site 0701

Moscow, , Russia

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Site 0901

Moscow, , Russia

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Site 0902

Moscow, , Russia

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Site 0903

Moscow, , Russia

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Site 0904

Moscow, , Russia

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Site 0905

Moscow, , Russia

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Site 0906

Moscow, , Russia

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Site 0907

Moscow, , Russia

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Site 0908

Moscow, , Russia

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Site 0909

Moscow, , Russia

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Site 0702

Saint Petersburg, , Russia

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Site 0703

Saint Petersburg, , Russia

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Site 0704

Saint Petersburg, , Russia

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Site 0705

Saint Petersburg, , Russia

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Site 0706

Saint Petersburg, , Russia

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Site 0707

Saint Petersburg, , Russia

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Site 2705

Bloemfontein, , South Africa

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Site 2703

Cape Town, , South Africa

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Site 2702

Centurion, , South Africa

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Site 2701

Roodepoort, , South Africa

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Site 2704

Roodepoort, , South Africa

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Site 3805

Dnipro, , Ukraine

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Site 3801

Donetsk, , Ukraine

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Site 3803

Kiev, , Ukraine

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Site 3806

Kiev, , Ukraine

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Site 3807

Kiev, , Ukraine

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Site 3808

Kiev, , Ukraine

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Site 3802

Odesa, , Ukraine

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Site 3804

Zaporizhzhya, , Ukraine

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Countries

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Australia Belgium Bulgaria Germany Romania Russia South Africa Ukraine

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