drugset / Trial / NCT00628121

Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer

NCT00628121

RandomizedParallel-groupSingle-blindTreatment

Summary

GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when administered in a single dose have been investigated in studies conducted using doses of 1, 3 and 5 mg. Studies performed in premenopausal female volunteers confirmed that cetrorelix rapidly suppresses luteinizing hormone (LH) and estradiol and shows dose-dependent prolongation of the duration of LH suppression. However, there have been few reports of studies of the relationship between the cetrorelix dosage and its effect on LH surge. In the present study, we investigated the effect of cetrorelix on LH surge when this drug was administered in single doses of 1, 2 and 3 mg.

Timeline

Start
2006-04
Primary completion
Completion
2007-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetrorelix Other / unclassified 1 mg Subcutaneous
Subject Cetrorelix Other / unclassified 2 mg Subcutaneous
Subject Cetrorelix Other / unclassified 3 mg Subcutaneous

Indications

No indication recorded.