Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer - Full Text View

Sponsors and Collaborators:	Nippon Kayaku Co.,Ltd. Shionogi AEterna Zentaris
Information provided by:	Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT00628121

Purpose

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.

Condition	Intervention
Premenopause	Drug: Cetrorelix

MedlinePlus related topics: Infertility

Drug Information available for: Cetrorelix Cetrorelix acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Pharmacodynamics Study
Official Title:	Clinical Pharmacological Study of NS75A for Healthy Adult Women

Further study details as provided by Nippon Kayaku Co.,Ltd.:

Primary Outcome Measures:

Day of the LH surge [ Time Frame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum LH concentrations [ Time Frame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle ] [ Designated as safety issue: No ]

Enrollment:	31
Study Start Date:	April 2006
Study Completion Date:	February 2007

Arms	Assigned Interventions
Cetrorelix 1 mg: Experimental	Drug: Cetrorelix 1, 2 or 3mg, subcutaneouly dosed with single dose
Cetrorelix 2 mg: Experimental	Drug: Cetrorelix 1, 2 or 3mg, subcutaneouly dosed with single dose
Cetrorelix 3 mg: Experimental	Drug: Cetrorelix 1, 2 or 3mg, subcutaneouly dosed with single dose

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 25 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628121

Locations

Japan, Kanagawa
Kitasato University East Hospital
Sagamihara, Kanagawa, Japan, 228-8520

Sponsors and Collaborators

Nippon Kayaku Co.,Ltd.

Shionogi

AEterna Zentaris

More Information

No publications provided

Responsible Party:	( Nippon Kayaku Co., Ltd. )
Study ID Numbers:	9575A402
Study First Received:	February 25, 2008
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00628121 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Nippon Kayaku Co.,Ltd.:

infertility, menstrual cycle, LH surge

Study placed in the following topic categories:

Infertility
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Cetrorelix
Healthy
Hormones

Additional relevant MeSH terms:

Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cetrorelix
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009