Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer
Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
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.