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

This study has been completed.
Sponsor:
Collaborators:
Shionogi
AEterna Zentaris
Information provided by:
Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00628121
First received: February 25, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Pharmacological Study of NS75A for Healthy Adult Women

Resource links provided by NLM:


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
Experimental: Cetrorelix 1 mg Drug: Cetrorelix
1, 2 or 3mg, subcutaneouly dosed with single dose
Other Name: NS75A
Experimental: Cetrorelix 2 mg Drug: Cetrorelix
1, 2 or 3mg, subcutaneouly dosed with single dose
Other Name: NS75A
Experimental: Cetrorelix 3 mg Drug: Cetrorelix
1, 2 or 3mg, subcutaneouly dosed with single dose
Other Name: NS75A

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
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.
ClinicalTrials.gov Identifier: NCT00628121     History of Changes
Other Study ID Numbers: 9575A402
Study First Received: February 25, 2008
Last Updated: February 25, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Nippon Kayaku Co.,Ltd.:
infertility, menstrual cycle, LH surge

Additional relevant MeSH terms:
Cetrorelix
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014