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临床试验/NCT04430621
NCT04430621Unknown4 期

Effects of Follicle-Stimulating Hormone Injection on Flow Mediated Dilation in Healthy Males

Federico II University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
16
试验地点
1
主要终点
Change in flow mediated dilation

研究概览

简要总结

Purpose of the study will be to evaluate the effects of the s.c. administration of 300 IU of FSH in 16 healthy males. The endothelial function will be evaluated by the measurement with ecographic approach of the flow mediated dilation (FMD) of the brachial artery. The FMD will be measured before and 6, 12, 24 or 48 hours after FSH or placebo adiministration in the same subjects studied 2 weeks apart. The results will help to clarify whether perturbation of FSH, similar to the one observed in women after the menopause, affect endothelial function.

详细描述

The effects of follicle-stimulating hormone (FSH) have been poorly studied. In women, FSH is involved in estrogen production, while in men regulates spermatogenesis. On the other hand, in women, menopause is associated with an increase in the risk of cardiovascular disease and the concentration of FSH rises. It is unclear whether such an increase has any effect on the development of atherosclerosis. Endothelial dysfunction represents an early trigger of atherosclerosis. Since estrogens can directly stimulate endothelial function and increase in response to FSH administration, males might represent a potential model to study the effcts of FSH independent from estrogens.Purpose of the study will be to evaluate the effects of the s.c. administration of 300 IU of FSH in 16 healthy males. The endothelial function will be evaluated by the measurement with ecographic approach of the flow mediated dilation (FMD) of the brachial artery. The FMD will be measured before and 6, 12, 24 or 48 hours after FSH or placebo adiministration in the same subjects studied 2 weeks apart. The results will help to clarify whether perturbation of FSH, similar to the one observed in women after the menopause, affects endothelial function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy volunteers -

排除标准

  • 未提供

研究组 & 干预措施

FSH

Experimental

FSH, 300 IU s.c.

干预措施: Follicle Stimulating Hormone (Drug)

Control

Placebo Comparator

Placebo, s.c.

干预措施: Follicle Stimulating Hormone (Drug)

结局指标

主要结局

Change in flow mediated dilation

时间窗: before and 48 hours after FSH or placebo administration

Evaluation of endothelial function of the brachial artery

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

RAFFAELE NAPOLI

Associate Professor

Federico II University

研究点 (1)

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