<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/NCT03245827</url>
  </required_header>
  <id_info>
    <org_study_id>28389</org_study_id>
    <nct_id>NCT03245827</nct_id>
  </id_info>
  <brief_title>Hypogonadotropic Hypogonadism in Obese Young Males</brief_title>
  <official_title>Hypogonadotropic Hypogonadism in Obese Young Males</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sandeep Singh Dhindsa, M.D., F.A.C.E</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity can lead to low testosterone concentrations in young men. This study will study the&#xD;
      effects of low testosterone in those men and the result of treating them with clomiphene.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of obesity has increased in children over the past few decades. Approximately&#xD;
      20% of adolescent boys are now considered obese. It is well accepted that obese children are&#xD;
      at increased risk for high blood pressure, lipid abnormalities and type 2 diabetes. Recent&#xD;
      studies have uncovered yet another undesirable effect of obesity. The testosterone levels of&#xD;
      obese boys are only half those of lean boys at completion of puberty. Testosterone is&#xD;
      important for muscle and bone development. Men with low testosterone are at higher risk of&#xD;
      insulin resistance and inflammation, which lead to type 2 diabetes and heart disease. Since&#xD;
      testosterone is the major reproductive hormone, these obese boys are at risk of decreased&#xD;
      fertility. Men are supposed to achieve their peak testosterone levels at puberty. Thereafter,&#xD;
      there is a decline in testosterone levels at the rate of 2% per year for the rest of life.&#xD;
      Thus there is a clear need to develop a deeper understanding of low testosterone in these&#xD;
      males who are entering their peak fertility years. There are no approved treatments for this&#xD;
      disorder. The investigators propose to conduct a randomized placebo controlled trial to&#xD;
      evaluate the effect of treatment with clomiphene in obese young men(age 18-30 years) who have&#xD;
      low testosterone concentrations. Clomiphene is a drug that increases testosterone&#xD;
      concentrations and possibly increases sperm production. In contrast, testosterone replacement&#xD;
      therapy decreased fertility and cannot be used in young men. Investigators will study the&#xD;
      effect of treatment with clomiphene or placebo tablets for 12 weeks in 30 subjects. The study&#xD;
      will evaluate:-&#xD;
&#xD;
        1. testicular function: Testosterone and two proteins secreted by testis(insulin like&#xD;
           factor 3 and inhibin B) will be measured in the blood before and after treatment with&#xD;
           clomiphene or placebo.&#xD;
&#xD;
        2. insulin resistance: Investigators will measure insulin and glucose levels in the blood.&#xD;
&#xD;
        3. inflammation: Investigators will measure proteins that induce inflammation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    not enough recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">October 29, 2021</completion_date>
  <primary_completion_date type="Actual">October 29, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum Free Testosterone</measure>
    <time_frame>12 weeks</time_frame>
    <description>after clomiphene or placebo treatment</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Hypogonadism, Hypogonadotropic</condition>
  <arm_group>
    <arm_group_label>Obese males with hypogonadism-active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be randomized to receive clomiphene capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese males with hypogonadism-placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will be randomized to receive placebo capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese males with normal testosterone</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>comparison group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lean males with normal testosterone</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>comparison group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clomiphene</intervention_name>
    <description>clomiphene capsule 25mg twice a week</description>
    <arm_group_label>Obese males with hypogonadism-active</arm_group_label>
    <other_name>active</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo capsule 25mg twice a week</description>
    <arm_group_label>Obese males with hypogonadism-placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Age 18-30 years inclusive will be recruited.&#xD;
&#xD;
        A total of 90 males will be recruited:-&#xD;
&#xD;
          -  30 obese males (defined as BMI ≥30 kg/m2) with HH,&#xD;
&#xD;
          -  30 obese males with normal FT concentrations and&#xD;
&#xD;
          -  30 lean males (defined as BMI &lt;25 kg/m2) with normal FT concentrations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of androgens, clomiphene, hCG, aromatase inhibitors or over the counter health&#xD;
             supplements which contain androgens currently or in the past 6 months&#xD;
&#xD;
          -  Hematocrit &gt; 50%&#xD;
&#xD;
          -  Congestive heart failure&#xD;
&#xD;
          -  currently suffering from depression&#xD;
&#xD;
          -  type 1 diabetes&#xD;
&#xD;
          -  Hepatic disease (transaminase &gt; 3 times normal) or cirrhosis&#xD;
&#xD;
          -  Renal impairment (eGFR&lt;30 ml/min/1.73m2)&#xD;
&#xD;
          -  HIV or Hepatitis C positive status&#xD;
&#xD;
          -  Participation in any other concurrent clinical trial&#xD;
&#xD;
          -  currently suffering from foot ulcer, significant periodontal disease or any other&#xD;
             chronic infectious condition&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>males</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>sandeep dhindsa, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Louis Univeristy</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <results_first_submitted>May 11, 2022</results_first_submitted>
  <results_first_submitted_qc>June 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 29, 2022</results_first_posted>
  <last_update_submitted>June 28, 2022</last_update_submitted>
  <last_update_submitted_qc>June 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Sandeep Singh Dhindsa, M.D., F.A.C.E</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypogonadism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clomiphene</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03245827/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Obese Males With Hypogonadism-active</title>
          <description>Subjects will be randomized to receive clomiphene capsules&#xD;
Clomiphene: clomiphene capsule 25mg twice a week</description>
        </group>
        <group group_id="P2">
          <title>Obese Males With Hypogonadism-placebo</title>
          <description>Subjects will be randomized to receive placebo capsules&#xD;
Placebo: placebo capsule 25mg twice a week</description>
        </group>
        <group group_id="P3">
          <title>Obese Males With Normal Testosterone</title>
          <description>comparison group</description>
        </group>
        <group group_id="P4">
          <title>Lean Males With Normal Testosterone</title>
          <description>comparison group</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>no subjects were recruited in placebo group</population>
      <group_list>
        <group group_id="B1">
          <title>Obese Males With Hypogonadism-active</title>
          <description>Subjects will be randomized to receive clomiphene capsules&#xD;
Clomiphene: clomiphene capsule 25mg twice a week</description>
        </group>
        <group group_id="B2">
          <title>Obese Males With Hypogonadism-placebo</title>
          <description>Subjects will be randomized to receive placebo capsules&#xD;
Placebo: placebo capsule 25mg twice a week</description>
        </group>
        <group group_id="B3">
          <title>Obese Males With Normal Testosterone</title>
          <description>comparison group</description>
        </group>
        <group group_id="B4">
          <title>Lean Males With Normal Testosterone</title>
          <description>comparison group</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="3"/>
            <count group_id="B4" value="5"/>
            <count group_id="B5" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22" spread="0"/>
                    <measurement group_id="B3" value="28" spread="2"/>
                    <measurement group_id="B4" value="21.8" spread="1.8"/>
                    <measurement group_id="B5" value="23.9" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Serum Free Testosterone</title>
        <description>after clomiphene or placebo treatment</description>
        <time_frame>12 weeks</time_frame>
        <population>Only one volunteer was randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Obese Males With Hypogonadism-active</title>
            <description>Subjects will be randomized to receive clomiphene capsules&#xD;
Clomiphene: clomiphene capsule 25mg twice a week</description>
          </group>
          <group group_id="O2">
            <title>Obese Males With Hypogonadism-placebo</title>
            <description>Subjects will be randomized to receive placebo capsules&#xD;
Placebo: placebo capsule 25mg twice a week</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Free Testosterone</title>
          <description>after clomiphene or placebo treatment</description>
          <population>Only one volunteer was randomized.</population>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" spread="NA">NA is used for standard deviation because there was only one volunteer.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <desc>no subjects were recruited in placebo group</desc>
      <group_list>
        <group group_id="E1">
          <title>Obese Males With Hypogonadism-active</title>
          <description>Subjects will be randomized to receive clomiphene capsules&#xD;
Clomiphene: clomiphene capsule 25mg twice a week</description>
        </group>
        <group group_id="E2">
          <title>Obese Males With Hypogonadism-placebo</title>
          <description>Subjects will be randomized to receive placebo capsules&#xD;
Placebo: placebo capsule 25mg twice a week</description>
        </group>
        <group group_id="E3">
          <title>Obese Males With Normal Testosterone</title>
          <description>comparison group</description>
        </group>
        <group group_id="E4">
          <title>Lean Males With Normal Testosterone</title>
          <description>comparison group</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sandeep Dhindsa</name_or_title>
      <organization>Saint Louis University</organization>
      <phone>716-977-4911</phone>
      <email>sandeep.dhindsa@health.slu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03245827
org study id: 28389
nct id: NCT03245827
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Obesity can lead to low testosterone concentrations in young men. This study will study the
      effects of low testosterone in those men and the result of treating them with clomiphene.
The prevalence of obesity has increased in children over the past few decades. Approximately
      20% of adolescent boys are now considered obese. It is well accepted that obese children are
      at increased risk for high blood pressure, lipid abnormalities and type 2 diabetes. Recent
      studies have uncovered yet another undesirable effect of obesity. The testosterone levels of
      obese boys are only half those of lean boys at completion of puberty. Testosterone is
      important for muscle and bone development. Men with low testosterone are at higher risk of
      insulin resistance and inflammation, which lead to type 2 diabetes and heart disease. Since
      testosterone is the major reproductive hormone, these obese boys are at risk of decreased
      fertility. Men are supposed to achieve their peak testosterone levels at puberty. Thereafter,
      there is a decline in testosterone levels at the rate of 2% per year for the rest of life.
      Thus there is a clear need to develop a deeper understanding of low testosterone in these
      males who are entering their peak fertility years. There are no approved treatments for this
      disorder. The investigators propose to conduct a randomized placebo controlled trial to
      evaluate the effect of treatment with clomiphene in obese young men(age 18-30 years) who have
      low testosterone concentrations. Clomiphene is a drug that increases testosterone
      concentrations and possibly increases sperm production. In contrast, testosterone replacement
      therapy decreased fertility and cannot be used in young men. Investigators will study the
      effect of treatment with clomiphene or placebo tablets for 12 weeks in 30 subjects. The study
      will evaluate:-

        1. testicular function: Testosterone and two proteins secreted by testis(insulin like
           factor 3 and inhibin B) will be measured in the blood before and after treatment with
           clomiphene or placebo.

        2. insulin resistance: Investigators will measure insulin and glucose levels in the blood.

        3. inflammation: Investigators will measure proteins that induce inflammation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Serum Free Testosterone
time frame: 12 weeks
description: after clomiphene or placebo treatment
arm group label: Obese males with hypogonadism-active
arm group type: Active Comparator
description: Subjects will be randomized to receive clomiphene capsules
arm group label: Obese males with hypogonadism-placebo
arm group type: Placebo Comparator
description: Subjects will be randomized to receive placebo capsules
arm group label: Obese males with normal testosterone
arm group type: No Intervention
description: comparison group
arm group label: lean males with normal testosterone
arm group type: No Intervention
description: comparison group
intervention type: Drug
intervention name: Clomiphene
description: clomiphene capsule 25mg twice a week
arm group label: Obese males with hypogonadism-active
other name: active
intervention type: Drug
intervention name: Placebo
description: placebo capsule 25mg twice a week
arm group label: Obese males with hypogonadism-placebo
criteria: 
gender: Male
gender based: Yes
gender description: males
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: sandeep dhindsa, md
role: Principal Investigator
affiliation: St. Louis University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: St. Louis University
investigator full name: Sandeep Singh Dhindsa, M.D., F.A.C.E
investigator title: Professor
mesh term: Hypogonadism
mesh term: Clomiphene
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 