Effects of FSH on Endothelial Function (FEND) (FEND)
Primary Purpose
Change in Flow Mediated Dilation
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Follicle Stimulating Hormone
Sponsored by
About this trial
This is an interventional basic science trial for Change in Flow Mediated Dilation focused on measuring endothelial function, atherosclerosis, FSH, FMD
Eligibility Criteria
Inclusion Criteria: Healthy volunteers -
Exclusion Criteria:
-
Sites / Locations
- Internal Medicine and Diabetes UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FSH
Control
Arm Description
FSH, 300 IU s.c.
Placebo, s.c.
Outcomes
Primary Outcome Measures
Change in flow mediated dilation
Evaluation of endothelial function of the brachial artery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04430621
Brief Title
Effects of FSH on Endothelial Function (FEND)
Acronym
FEND
Official Title
Effects of Follicle-Stimulating Hormone Injection on Flow Mediated Dilation in Healthy Males
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
August 10, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Change in Flow Mediated Dilation
Keywords
endothelial function, atherosclerosis, FSH, FMD
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FSH
Arm Type
Experimental
Arm Description
FSH, 300 IU s.c.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo, s.c.
Intervention Type
Drug
Intervention Name(s)
Follicle Stimulating Hormone
Intervention Description
FSH will be administered s.c. in the morning to male healthy subjects
Primary Outcome Measure Information:
Title
Change in flow mediated dilation
Description
Evaluation of endothelial function of the brachial artery
Time Frame
before and 48 hours after FSH or placebo administration
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers -
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raffaele Napoli, MD
Phone
+390817463736
Email
napoli@unina.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raffaele Napoli, MD
Organizational Affiliation
University Federico II
Official's Role
Principal Investigator
Facility Information:
Facility Name
Internal Medicine and Diabetes Unit
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele Napoli, MD
Phone
+390817463736
Email
napoli@unina.it
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of FSH on Endothelial Function (FEND)
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