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.

First Received: October 25, 2005 Last Updated: March 28, 2008 History of Changes

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00244452

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 II

MedlinePlus related topics: Endometriosis

Drug Information available for: Cetrorelix Cetrorelix acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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:	Solvay Pharmaceuticals ( Gereon Raddatz )
Study ID Numbers:	S184.2.101, 2004-004739-67
Study First Received:	October 25, 2005
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00244452 History of Changes
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

Study placed in the following topic categories:

Genital Diseases, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Cetrorelix
Endometriosis
Hormones

Additional relevant MeSH terms:

Genital Diseases, Female
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Cetrorelix
Endometriosis
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009