Effects of Follicle-Stimulating Hormone Injection on Flow Mediated Dilation in Healthy Males
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
- 是
入选标准
- •Healthy volunteers -
排除标准
- 未提供
研究组 & 干预措施
FSH
FSH, 300 IU s.c.
干预措施: Follicle Stimulating Hormone (Drug)
Control
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
RAFFAELE NAPOLI
Associate Professor
Federico II University
