Effects of FSH on Endothelial Function (FEND)

Change in Flow Mediated Dilation Clinical Trial

— FEND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04430621
• Other study ID #: FSH1
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: June 2020
• Source: Federico II University
• Contact: Raffaele Napoli, MD
• Phone: +390817463736
• Email: napoli[@]unina.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: August 31, 2020
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria: Healthy volunteers -

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Change in Flow Mediated Dilation

Intervention

Drug:
• Follicle Stimulating Hormone
FSH will be administered s.c. in the morning to male healthy subjects

Locations

Country	Name	City	State
Italy	Internal Medicine and Diabetes Unit	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in flow mediated dilation	Evaluation of endothelial function of the brachial artery	before and 48 hours after FSH or placebo administration