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Effects of FSH on Endothelial Function (FEND)

NCT04430621 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-06-12

No results posted yet for this study

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.

Conditions

  • Change in Flow Mediated Dilation

Interventions

DRUG

Follicle Stimulating Hormone

FSH will be administered s.c. in the morning to male healthy subjects

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Raffaele Napoli, MD · University Federico II

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2020-08-10
Completion
2020-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04430621 on ClinicalTrials.gov