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Clinical Trials/NCT04430621
NCT04430621UnknownPhase 4

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

Federico II University1 site in 1 country16 target enrollmentStarted: July 1, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
16
Locations
1
Primary Endpoint
Change in flow mediated dilation

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy volunteers -

Exclusion Criteria

  • Not provided

Arms & Interventions

FSH

Experimental

FSH, 300 IU s.c.

Intervention: Follicle Stimulating Hormone (Drug)

Control

Placebo Comparator

Placebo, s.c.

Intervention: Follicle Stimulating Hormone (Drug)

Outcomes

Primary Outcomes

Change in flow mediated dilation

Time Frame: before and 48 hours after FSH or placebo administration

Evaluation of endothelial function of the brachial artery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Federico II University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

RAFFAELE NAPOLI

Associate Professor

Federico II University

Study Sites (1)

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