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 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

Drug Information available for: Cetrorelix Cetrorelix acetate

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 (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

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, see Learn About Clinical Studies.

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


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

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

ClinicalTrials.gov processed this record on July 27, 2017

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