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

February 25, 2008 updated by: Nippon Kayaku Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cetrorelix 1 mg
Drug: Cetrorelix
1, 2 or 3mg, subcutaneouly dosed with single dose
Other Names:
  • NS75A
Experimental: Cetrorelix 2 mg
Drug: Cetrorelix
1, 2 or 3mg, subcutaneouly dosed with single dose
Other Names:
  • NS75A
Experimental: Cetrorelix 3 mg
Drug: Cetrorelix
1, 2 or 3mg, subcutaneouly dosed with single dose
Other Names:
  • NS75A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Day of the LH surge
Time Frame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle
Saline administration menstrual cycle, cetrorelix administration menstrual cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum LH concentrations
Time Frame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle
Saline administration menstrual cycle, cetrorelix administration menstrual cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nippon Kayaku Co., Ltd.

Collaborators

Shionogi
AEterna Zentaris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

February 25, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

March 4, 2008

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

February 25, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9575A402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Premenopause

Clinical Trials on Cetrorelix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe