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

Study Overview
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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.

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.

Official Title
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Clinical Pharmacological Study of NS75A for Healthy Adult Women

Conditions
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Premenopause

Intervention / Treatment
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* Drug: Cetrorelix


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cetrorelix 1 mg<br> | Drug: Cetrorelix<br>* 1, 2 or 3mg, subcutaneouly dosed with single dose<br>* Other names: NS75A;|
| Experimental: Cetrorelix 2 mg<br> | Drug: Cetrorelix<br>* 1, 2 or 3mg, subcutaneouly dosed with single dose<br>* Other names: NS75A;|
| Experimental: Cetrorelix 3 mg<br> | Drug: Cetrorelix<br>* 1, 2 or 3mg, subcutaneouly dosed with single dose<br>* Other names: NS75A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day of the LH surge |  | Saline administration menstrual cycle, cetrorelix administration menstrual cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum LH concentrations |  | Saline administration menstrual cycle, cetrorelix administration menstrual cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility, menstrual cycle, LH surge