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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:
ClinicalTrials.gov Identifier:
NCT00244452
First Posted: October 26, 2005
Last Update Posted: March 31, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solvay Pharmaceuticals
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244452


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

Responsible Party: Gereon Raddatz, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00244452     History of Changes
Other Study ID Numbers: S184.2.101
2004-004739-67
First Submitted: October 25, 2005
First Posted: October 26, 2005
Last Update Posted: March 31, 2008
Last Verified: March 2008

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Cetrorelix
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists