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

March 28, 2008 updated by: Solvay Pharmaceuticals
Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Clayton, Australia
        • Site 6101
      • Nedlands, Australia
        • Site 6103
      • Randwick, Australia
        • Site 6104
      • Sydney, Australia
        • Site 6102
  • Belgium
      • Aalter, Belgium
        • Site 3201
      • Brussels, Belgium
        • Site 3202
      • Leuven, Belgium
        • Site 3203
  • Bulgaria
      • Sofia, Bulgaria
        • Site 3501
      • Sofia, Bulgaria
        • Site 3502
      • Sofia, Bulgaria
        • Site 3503
      • Sofia, Bulgaria
        • Site 3504
      • Sofia, Bulgaria
        • Site 3505
      • Sofia, Bulgaria
        • Site 3506
  • Germany
      • Berlin, Germany
        • Site 4904
      • Dresden, Germany
        • Site 4905
      • Heidelberg, Germany
        • Site 4903
      • Herne, Germany
        • Site 4901
      • Tuebingen, Germany
        • Site 4902
  • Romania
      • Bucuresti, 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
      • Constanta, Romania
        • Site 4008
      • Craiova, Romania
        • Site 4003
  • Russian Federation
      • Moscow, Russian Federation
        • Site 0901
      • Moscow, Russian Federation
        • Site 0904
      • Moscow, Russian Federation
        • Site 0908
      • Moscow, Russian Federation
        • Site 0909
      • Moscow, Russian Federation
        • Site 0701
      • Moscow, Russian Federation
        • Site 0902
      • Moscow, Russian Federation
        • Site 0903
      • Moscow, Russian Federation
        • Site 0905
      • Moscow, Russian Federation
        • Site 0906
      • Moscow, Russian Federation
        • Site 0907
      • St. Petersburg, 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
  • South Africa
      • Bloemfontein, South Africa
        • Site 2705
      • Cape Town, South Africa
        • Site 2703
      • Centurion, South Africa
        • Site 2702
      • Roodepoort, South Africa
        • Site 2701
      • Roodepoort, South Africa
        • Site 2704
  • Ukraine
      • Dnepropetrovsk, Ukraine
        • Site 3805
      • Donetsk, Ukraine
        • Site 3801
      • Kiev, Ukraine
        • Site 3803
      • Kiev, Ukraine
        • Site 3806
      • Kiev, Ukraine
        • Site 3807
      • Kiev, Ukraine
        • Site 3808
      • Odessa, Ukraine
        • Site 3802
      • Zaporozhye, Ukraine
        • Site 3804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

October 25, 2005

First Submitted That Met QC Criteria

October 25, 2005

First Posted (Estimate)

October 26, 2005

Study Record Updates

Last Update Posted (Estimate)

March 31, 2008

Last Update Submitted That Met QC Criteria

March 28, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S184.2.101
  • 2004-004739-67

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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