NCT00628121

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2008

Completed
Last Updated

March 4, 2008

Status Verified

February 1, 2008

First QC Date

February 25, 2008

Last Update Submit

February 25, 2008

Conditions

Premenopause

Keywords

infertility, menstrual cycle, LH surge

Outcome Measures

Primary Outcomes (1)

  • Day of the LH surge

    Saline administration menstrual cycle, cetrorelix administration menstrual cycle

Secondary Outcomes (1)

  • Serum LH concentrations

    Saline administration menstrual cycle, cetrorelix administration menstrual cycle

Study Arms (3)

Cetrorelix 1 mg

EXPERIMENTAL
Drug: Cetrorelix

Cetrorelix 2 mg

EXPERIMENTAL
Drug: Cetrorelix

Cetrorelix 3 mg

EXPERIMENTAL
Drug: Cetrorelix

Interventions

CetrorelixDRUG

1, 2 or 3mg, subcutaneouly dosed with single dose

Also known as: NS75A
Cetrorelix 1 mgCetrorelix 2 mgCetrorelix 3 mg

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • a BMI of 18 years old and \<18 and 25 years old and \>25
  • menstrual cycles was within the range of 25\~31 days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kitasato University East Hospital

Sagamihara, Kanagawa, 228-8520, Japan

Location

MeSH Terms

Conditions

Infertility

Interventions

cetrorelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 4, 2008

Study Start

April 1, 2006

Study Completion

February 1, 2007

Last Updated

March 4, 2008

Record last verified: 2008-02

Locations

JP(1)