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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

February 25, 2008
February 25, 2008
April 2006
Not Provided
Day of the LH surge [ Time Frame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Serum LH concentrations [ Time Frame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer
Clinical Pharmacological Study of NS75A for Healthy Adult Women

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Premenopause
Drug: Cetrorelix
1, 2 or 3mg, subcutaneouly dosed with single dose
Other Name: NS75A
  • Experimental: Cetrorelix 1 mg
    Intervention: Drug: Cetrorelix
  • Experimental: Cetrorelix 2 mg
    Intervention: Drug: Cetrorelix
  • Experimental: Cetrorelix 3 mg
    Intervention: Drug: Cetrorelix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
February 2007
Not Provided

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
Female
18 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00628121
9575A402
No
Nippon Kayaku Co., Ltd.
Nippon Kayaku Co.,Ltd.
  • Shionogi
  • AEterna Zentaris
Not Provided
Nippon Kayaku Co.,Ltd.
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP