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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nippon Kayaku Co., Ltd.; Nippon Kayaku Co.,Ltd.
• Collaborators: AEterna Zentaris; Shionogi
• Treatments: Cetrorelix

Criteria

Inclusion Criteria:

• a BMI of 18 years old and <18 and 25 years old and >25

• menstrual cycles was within the range of 25~31 days

Exclusion Criteria:

• use of a drug (e.g., oral contraceptives, drugs for treatment of hyperprolactinemia, GnRH agonists, sex steroid hormones, psychoactive drugs, etc.)

• serious disease of the endocrine system, liver, kidney, heart, lung, digestive system, etc.

• a generalized drug allergy