NCT04430621

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

June 10, 2020

Last Update Submit

June 10, 2020

Conditions

Change in Flow Mediated Dilation

Keywords

endothelial function, atherosclerosis, FSH, FMD

Outcome Measures

Primary Outcomes (1)

  • Change in flow mediated dilation

    Evaluation of endothelial function of the brachial artery

    before and 48 hours after FSH or placebo administration

Study Arms (2)

FSH

EXPERIMENTAL

FSH, 300 IU s.c.

Drug: Follicle Stimulating Hormone

Control

PLACEBO COMPARATOR

Placebo, s.c.

Drug: Follicle Stimulating Hormone

Interventions

Follicle Stimulating HormoneDRUG

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

ControlFSH

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal Medicine and Diabetes Unit

Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Interventions

Follicle Stimulating Hormone

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Raffaele Napoli, MD

    University Federico II

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaele Napoli, MD

CONTACT

+390817463736napoli@unina.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 12, 2020

Study Start

July 1, 2020

Primary Completion

August 10, 2020

Study Completion

August 31, 2020

Last Updated

June 12, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)