<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04430621</url>
  </required_header>
  <id_info>
    <org_study_id>FSH1</org_study_id>
    <nct_id>NCT04430621</nct_id>
  </id_info>
  <brief_title>Effects of FSH on Endothelial Function (FEND)</brief_title>
  <acronym>FEND</acronym>
  <official_title>Effects of Follicle-Stimulating Hormone Injection on Flow Mediated Dilation in Healthy Males</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of the study will be to evaluate the effects of the s.c. administration of 300 IU of&#xD;
      FSH in 16 healthy males. The endothelial function will be evaluated by the measurement with&#xD;
      ecographic approach of the flow mediated dilation (FMD) of the brachial artery. The FMD will&#xD;
      be measured before and 6, 12, 24 or 48 hours after FSH or placebo adiministration in the same&#xD;
      subjects studied 2 weeks apart. The results will help to clarify whether perturbation of FSH,&#xD;
      similar to the one observed in women after the menopause, affect endothelial function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effects of follicle-stimulating hormone (FSH) have been poorly studied. In women, FSH is&#xD;
      involved in estrogen production, while in men regulates spermatogenesis. On the other hand,&#xD;
      in women, menopause is associated with an increase in the risk of cardiovascular disease and&#xD;
      the concentration of FSH rises. It is unclear whether such an increase has any effect on the&#xD;
      development of atherosclerosis. Endothelial dysfunction represents an early trigger of&#xD;
      atherosclerosis. Since estrogens can directly stimulate endothelial function and increase in&#xD;
      response to FSH administration, males might represent a potential model to study the effcts&#xD;
      of FSH independent from estrogens.Purpose of the study will be to evaluate the effects of the&#xD;
      s.c. administration of 300 IU of FSH in 16 healthy males. The endothelial function will be&#xD;
      evaluated by the measurement with ecographic approach of the flow mediated dilation (FMD) of&#xD;
      the brachial artery. The FMD will be measured before and 6, 12, 24 or 48 hours after FSH or&#xD;
      placebo adiministration in the same subjects studied 2 weeks apart. The results will help to&#xD;
      clarify whether perturbation of FSH, similar to the one observed in women after the&#xD;
      menopause, affects endothelial function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 10, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in flow mediated dilation</measure>
    <time_frame>before and 48 hours after FSH or placebo administration</time_frame>
    <description>Evaluation of endothelial function of the brachial artery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Change in Flow Mediated Dilation</condition>
  <arm_group>
    <arm_group_label>FSH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FSH, 300 IU s.c.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, s.c.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Follicle Stimulating Hormone</intervention_name>
    <description>FSH will be administered s.c. in the morning to male healthy subjects</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>FSH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Healthy volunteers -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raffaele Napoli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Federico II</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Raffaele Napoli, MD</last_name>
    <phone>+390817463736</phone>
    <email>napoli@unina.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Internal Medicine and Diabetes Unit</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raffaele Napoli, MD</last_name>
      <phone>+390817463736</phone>
      <email>napoli@unina.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>RAFFAELE NAPOLI</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>endothelial function, atherosclerosis, FSH, FMD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dilatation, Pathologic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</mesh_term>
    <mesh_term>Follicle Stimulating Hormone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04430621
org study id: FSH1
nct id: NCT04430621
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in flow mediated dilation
time frame: before and 48 hours after FSH or placebo administration
description: Evaluation of endothelial function of the brachial artery
arm group label: FSH
arm group type: Experimental
description: FSH, 300 IU s.c.
arm group label: Control
arm group type: Placebo Comparator
description: Placebo, s.c.
intervention type: Drug
intervention name: Follicle Stimulating Hormone
description: FSH will be administered s.c. in the morning to male healthy subjects
arm group label: Control
arm group label: FSH
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Raffaele Napoli, MD
role: Principal Investigator
affiliation: University Federico II
last name: Raffaele Napoli, MD
phone: +390817463736
email: napoli@unina.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: RAFFAELE NAPOLI
investigator title: Associate Professor
mesh term: Dilatation, Pathologic
mesh term: Hormones
mesh term: Follicle Stimulating Hormone
sharing ipd: No