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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Premenopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cetrorelix 1 mg

Group Type EXPERIMENTAL

Cetrorelix

Intervention Type DRUG

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

Cetrorelix 2 mg

Group Type EXPERIMENTAL

Cetrorelix

Intervention Type DRUG

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

Cetrorelix 3 mg

Group Type EXPERIMENTAL

Cetrorelix

Intervention Type DRUG

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

Interventions

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Cetrorelix

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

Intervention Type DRUG

Other Intervention Names

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NS75A

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes