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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

Primary Purpose

Endometriosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cetrorelix
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Cetrorelix, Hormone, Symptoms relief, Safety, Tolerability, Pharmacodynamic, Pharmacokinetic

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Site 6101
  • Site 6103
  • Site 6104
  • Site 6102
  • Site 3201
  • Site 3202
  • Site 3203
  • Site 3501
  • Site 3502
  • Site 3503
  • Site 3504
  • Site 3505
  • Site 3506
  • Site 4904
  • Site 4905
  • Site 4903
  • Site 4901
  • Site 4902
  • Site 4000
  • Site 4001
  • Site 4002
  • Site 4004
  • Site 4005
  • Site 4006
  • Site 4007
  • Site 4009
  • Site 4008
  • Site 4003
  • Site 0701
  • Site 0901
  • Site 0902
  • Site 0903
  • Site 0904
  • Site 0905
  • Site 0906
  • Site 0907
  • Site 0908
  • Site 0909
  • Site 0702
  • Site 0703
  • Site 0704
  • Site 0705
  • Site 0706
  • Site 0707
  • Site 2705
  • Site 2703
  • Site 2702
  • Site 2701
  • Site 2704
  • Site 3805
  • Site 3801
  • Site 3803
  • Site 3806
  • Site 3807
  • Site 3808
  • Site 3802
  • Site 3804

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 25, 2005
Last Updated
March 28, 2008
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00244452
Brief 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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Cetrorelix, Hormone, Symptoms relief, Safety, Tolerability, Pharmacodynamic, Pharmacokinetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cetrorelix

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 6101
City
Clayton
Country
Australia
Facility Name
Site 6103
City
Nedlands
Country
Australia
Facility Name
Site 6104
City
Randwick
Country
Australia
Facility Name
Site 6102
City
Sydney
Country
Australia
Facility Name
Site 3201
City
Aalter
Country
Belgium
Facility Name
Site 3202
City
Brussels
Country
Belgium
Facility Name
Site 3203
City
Leuven
Country
Belgium
Facility Name
Site 3501
City
Sofia
Country
Bulgaria
Facility Name
Site 3502
City
Sofia
Country
Bulgaria
Facility Name
Site 3503
City
Sofia
Country
Bulgaria
Facility Name
Site 3504
City
Sofia
Country
Bulgaria
Facility Name
Site 3505
City
Sofia
Country
Bulgaria
Facility Name
Site 3506
City
Sofia
Country
Bulgaria
Facility Name
Site 4904
City
Berlin
Country
Germany
Facility Name
Site 4905
City
Dresden
Country
Germany
Facility Name
Site 4903
City
Heidelberg
Country
Germany
Facility Name
Site 4901
City
Herne
Country
Germany
Facility Name
Site 4902
City
Tuebingen
Country
Germany
Facility Name
Site 4000
City
Bucuresti
Country
Romania
Facility Name
Site 4001
City
Bucuresti
Country
Romania
Facility Name
Site 4002
City
Bucuresti
Country
Romania
Facility Name
Site 4004
City
Bucuresti
Country
Romania
Facility Name
Site 4005
City
Bucuresti
Country
Romania
Facility Name
Site 4006
City
Bucuresti
Country
Romania
Facility Name
Site 4007
City
Bucuresti
Country
Romania
Facility Name
Site 4009
City
Bucuresti
Country
Romania
Facility Name
Site 4008
City
Constanta
Country
Romania
Facility Name
Site 4003
City
Craiova
Country
Romania
Facility Name
Site 0701
City
Moscow
Country
Russian Federation
Facility Name
Site 0901
City
Moscow
Country
Russian Federation
Facility Name
Site 0902
City
Moscow
Country
Russian Federation
Facility Name
Site 0903
City
Moscow
Country
Russian Federation
Facility Name
Site 0904
City
Moscow
Country
Russian Federation
Facility Name
Site 0905
City
Moscow
Country
Russian Federation
Facility Name
Site 0906
City
Moscow
Country
Russian Federation
Facility Name
Site 0907
City
Moscow
Country
Russian Federation
Facility Name
Site 0908
City
Moscow
Country
Russian Federation
Facility Name
Site 0909
City
Moscow
Country
Russian Federation
Facility Name
Site 0702
City
St. Petersburg
Country
Russian Federation
Facility Name
Site 0703
City
St. Petersburg
Country
Russian Federation
Facility Name
Site 0704
City
St. Petersburg
Country
Russian Federation
Facility Name
Site 0705
City
St. Petersburg
Country
Russian Federation
Facility Name
Site 0706
City
St. Petersburg
Country
Russian Federation
Facility Name
Site 0707
City
St. Petersburg
Country
Russian Federation
Facility Name
Site 2705
City
Bloemfontein
Country
South Africa
Facility Name
Site 2703
City
Cape Town
Country
South Africa
Facility Name
Site 2702
City
Centurion
Country
South Africa
Facility Name
Site 2701
City
Roodepoort
Country
South Africa
Facility Name
Site 2704
City
Roodepoort
Country
South Africa
Facility Name
Site 3805
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Site 3801
City
Donetsk
Country
Ukraine
Facility Name
Site 3803
City
Kiev
Country
Ukraine
Facility Name
Site 3806
City
Kiev
Country
Ukraine
Facility Name
Site 3807
City
Kiev
Country
Ukraine
Facility Name
Site 3808
City
Kiev
Country
Ukraine
Facility Name
Site 3802
City
Odessa
Country
Ukraine
Facility Name
Site 3804
City
Zaporozhye
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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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