Effects of FSH on Endothelial Function (FEND)

Federico II University

Status and phase: Unknown; Phase 4

Conditions: Change in Flow Mediated Dilation

Treatments: Drug: Follicle Stimulating Hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT04430621

FSH1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Healthy volunteers -

Exclusion Criteria:

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 2 patient groups, including a placebo group

FSH

Experimental group

Description:

FSH, 300 IU s.c.

Treatment:

Drug: Follicle Stimulating Hormone

Control

Placebo Comparator group

Description:

Placebo, s.c.

Treatment:

Drug: Follicle Stimulating Hormone