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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

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
History of Changes
  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:

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

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 May 19, 2013