Effects of FSH on Endothelial Function (FEND)

Phase 4

• Conditions: Change in Flow Mediated Dilation
• Interventions: Drug: Follicle Stimulating Hormone

• Registration Number: NCT04430621
• Lead Sponsor: Federico II University

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 Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Last Update Submitted: 2020-06-10
• Study First Posted: 2020-06-12
• Last Update Posted: 2020-06-12
• Study Start: 2020-07-01
• Primary Completion: 2020-08-10
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Healthy volunteers -

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FSH	Follicle Stimulating Hormone	FSH, 300 IU s.c.
Control	Follicle Stimulating Hormone	Placebo, s.c.

Primary Outcome Measures

Name	Time	Method
Change in flow mediated dilation	before and 48 hours after FSH or placebo administration	Evaluation of endothelial function of the brachial artery

Trial Locations

Locations (1)

Internal Medicine and Diabetes Unit; 🇮🇹 Napoli, Italy