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

Premenopause Clinical Trial

Official title:

Clinical Pharmacological Study of NS75A for Healthy Adult Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628121
• Other study ID #: 9575A402
• Status: Completed
• Phase: N/A
• First received: February 25, 2008
• Last updated: February 25, 2008
• Start date: April 2006
• Est. completion date: February 2007

Study information

• Verified date: February 2008
• Source: Nippon Kayaku Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

To evaluate that effect on LH surge, we investigated the efficacy of cetrorelix in delaying the start of the LH surge in comparison with the control menstrual cycle when saline was administered, and also examined the mode of disappearance of pulsatile LH secretion during the cetrorelix administration menstrual cycle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premenopause

Intervention

Drug:
• Cetrorelix
1, 2 or 3mg, subcutaneouly dosed with single dose

Locations

Country	Name	City	State
Japan	Kitasato University East Hospital	Sagamihara	Kanagawa

Sponsors (3)

Lead Sponsor	Collaborator
Nippon Kayaku Co.,Ltd.	AEterna Zentaris, Shionogi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Day of the LH surge		Saline administration menstrual cycle, cetrorelix administration menstrual cycle	No
Secondary	Serum LH concentrations		Saline administration menstrual cycle, cetrorelix administration menstrual cycle	No