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Sponsored by: |
Solvay Pharmaceuticals |
---|---|
Information provided by: | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00244452 |
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 |
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 |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
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 |
Endometriosis Cetrorelix Hormone Symptoms relief |
Safety Tolerability Pharmacodynamic Pharmacokinetic |
Genital Diseases, Female Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Cetrorelix Endometriosis Hormones |
Genital Diseases, Female Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Cetrorelix Endometriosis Pharmacologic Actions |