Effects of FSH on Endothelial Function (FEND)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Change in Flow Mediated Dilation

Intervention / Treatment
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* Drug: Follicle Stimulating Hormone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers - Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FSH<br>FSH, 300 IU s.c. | Drug: Follicle Stimulating Hormone<br>* FSH will be administered s.c. in the morning to male healthy subjects<br>|
| Placebo Comparator: Control<br>Placebo, s.c. | Drug: Follicle Stimulating Hormone<br>* FSH will be administered s.c. in the morning to male healthy subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in flow mediated dilation | Evaluation of endothelial function of the brachial artery | before and 48 hours after FSH or placebo administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, atherosclerosis, FSH, FMD