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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00244452
First received: October 25, 2005
Last updated: March 28, 2008
Last verified: March 2008
  Purpose

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


Condition Intervention Phase
Endometriosis
Drug: Cetrorelix
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: November 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244452

  Show 57 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Gereon Raddatz, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00244452     History of Changes
Other Study ID Numbers: S184.2.101, 2004-004739-67
Study First Received: October 25, 2005
Last Updated: March 28, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Russia: Pharmacological Committee, Ministry of Health
Romania: State Institute for Drug Control
Bulgaria: Ministry of Health
Belgium: Ministry of Social Affairs, Public Health and the Environment
Australia: National Health and Medical Research Council

Keywords provided by Solvay Pharmaceuticals:
Endometriosis
Cetrorelix
Hormone
Symptoms relief
Safety
Tolerability
Pharmacodynamic
Pharmacokinetic

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Cetrorelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014