<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/NCT04439799</url>
  </required_header>
  <id_info>
    <org_study_id>20200201</org_study_id>
    <nct_id>NCT04439799</nct_id>
  </id_info>
  <brief_title>A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections</brief_title>
  <official_title>A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections: A Phase IV, Prospective, Randomized, Non-Blinded, Multi-Institutional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Acerus Pharmaceuticals Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to evaluate changes in vascular parameters and the prevalence of&#xD;
      side effects in subjects receiving 1 cc (200mg) every 2 weeks intramuscular (IM) of&#xD;
      Testosterone Cypionate versus subjects receiving 11mg three times daily (TID) Natesto to&#xD;
      participant with clinical hypogonadism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Administration of exogenous testosterone as efficacious treatment for male hypogonadism has&#xD;
      been part of medical practice for more than 50 years. Testosterone replacement therapy (TRT)&#xD;
      is becoming more widely available and has seen a greater than three-fold increase in use in&#xD;
      men 40 years and older. Current delivery systems of TRT include transdermal gels and patches,&#xD;
      intranasal gels (currently marketed as Natesto), injection therapy, and long acting&#xD;
      subcutaneous pellets.&#xD;
&#xD;
      Natesto is a short-acting formulation of testosterone delivered intranasally to men diagnosed&#xD;
      with low T. This has the potential to avoid side effects related to TRT that are commonly&#xD;
      seen with other delivery methods, namely polycythemia, acne, male-pattern hair loss,&#xD;
      azoospermia and hyperestrogenemia.&#xD;
&#xD;
      Testosterone Cypionate injections are the most common form of TRT in the USA. Testosterone&#xD;
      Cypionate has many reported side effects, the most common being polycythemia, gynecomastia,&#xD;
      hair loss, acne, decreased spermatogenesis, and testicular atrophy. In a multicenter&#xD;
      retrospective study, it has been shown that the prevalence of polycythemia in men on&#xD;
      testosterone replacement (injections) was 11.2%. In this study, we will compare hematocrit&#xD;
      changes caused by treatment with Testosterone Cypionate and Natesto in a parallel arm,&#xD;
      randomized study. To date, there have been no direct head-to-haed comparisons of these&#xD;
      formulations.&#xD;
&#xD;
      We hypothesize that the short-acting pharmacokinetics of Natesto more closely resembles the&#xD;
      natural pulsatility of testosterone and therefore can avoid side effects traditionally seen&#xD;
      in long-acting, exogenous testosterone formulations&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 7, 2020</start_date>
  <completion_date type="Anticipated">June 15, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2023</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Hematocrit (Hct) levels.</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>Changes in serum Hct levels will be assessed in %</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in gonadotropin levels</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>Change in serum gonadotropin levels including Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH), both assessed in mIU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hormone levels</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>Change in serum hormone levels including Testosterone, 17 -Hydroxyprogesterone (17-OHP) and Dihydrotestosterone (DHT), all assessed in ng/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PSA levels</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>Change in serum Prostate Specific Antigen (PSA) levels will be assessed in ng/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in estrogen levels</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>Change in serum estrogen levels will be assessed in pg/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Testicular Volume</measure>
    <time_frame>baseline, 4 months</time_frame>
    <description>changes in testicular volume will be assessed in cc. An orchidometer will be the instrument of assessment during physical exam.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in IIEF score</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>The International Index of Erectile Function (IIEF)-15 is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>8. Change in SF-15 Erectile Function Domain Scores</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>The Short Form (SF)-15 Questionnaire Erectile Function domain has a total score ranging from 0-25 with the higher score indicating better erectile function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-15 Intercourse Satisfaction Domain Scores</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>The SF-15 Questionnaire Intercourse Satisfaction domain has a total score ranging from 0-15 with the higher score indicating better intercourse satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-15 Questionnaire Scores</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>The SF-15 Questionnaire Orgasmic Function, Sexual Desire and Overall Satisfaction domains each has a total score ranging from 0-10 with the higher score indicating better outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Hypogonadism, Male</condition>
  <arm_group>
    <arm_group_label>Testosterone Cypionate Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Natesto Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone Cypionate 200 MG/ML</intervention_name>
    <description>Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.</description>
    <arm_group_label>Testosterone Cypionate Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intranasal Testosterone</intervention_name>
    <description>Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as two or three daily doses (5.5 mg per nostril, 11.0 mg single dose) for 4 consecutive months,</description>
    <arm_group_label>Natesto Group</arm_group_label>
    <other_name>Natesto</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntarily sign and date the study consent form(s), which have been approved by an&#xD;
             Institutional Review Board (IRB). Written consent must be obtained prior to the&#xD;
             initiation of any study procedures.&#xD;
&#xD;
          2. Documented diagnosis of primary hypogonadism (congenital or acquired) or&#xD;
             hypogonadotropic hypogonadism (congenital or acquired).&#xD;
&#xD;
          3. Serum total testosterone &lt; 300 ng/dL on 2 measurements&#xD;
&#xD;
          4. Naïve to androgen replacement or has discontinued current treatment and completed a&#xD;
             washout of 4 months following androgen treatment.&#xD;
&#xD;
          5. Men deemed to be candidates for TRT based on the results of a medical history,&#xD;
             physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram&#xD;
             (ECG).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of significant sensitivity or allergy to androgens, or product excipients.&#xD;
&#xD;
          2. Clinically significant findings in the pre-study examinations including abnormal&#xD;
             breast examination requiring follow-up, abnormal ECG.&#xD;
&#xD;
          3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s)&#xD;
&#xD;
          4. Body mass index (BMI) ≥ 40 kg/m2.&#xD;
&#xD;
          5. Clinically significant abnormal laboratory value, in the opinion of the investigator,&#xD;
             in serum chemistry, hematology, or urinalysis including but not limited to:&#xD;
&#xD;
               1. Baseline hemoglobin &gt; 16 g/dL or HCT 48%&#xD;
&#xD;
               2. PSA &gt; 4 ng/mL&#xD;
&#xD;
          6. History of seizures or convulsions, including febrile, alcohol or drug withdrawal&#xD;
             seizures.&#xD;
&#xD;
          7. History of any clinically significant illness, infection, or surgical procedure within&#xD;
             4 weeks prior to study drug administration.&#xD;
&#xD;
          8. History of stroke or myocardial infarction within the past 5 years.&#xD;
&#xD;
          9. History of, or current or suspected, prostate or breast cancer.&#xD;
&#xD;
         10. History of diagnosed, severe, untreated, obstructive sleep apnea.&#xD;
&#xD;
         11. History of abuse of alcohol or any drug substance in the opinion of the investigator&#xD;
             within the previous 2 years.&#xD;
&#xD;
         12. Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt&#xD;
             of a transfusion of any blood product within 12 weeks prior to the start of treatment.&#xD;
&#xD;
         13. Inadequate venous access for collection of serial blood samples required for&#xD;
             pharmacokinetic profiles.&#xD;
&#xD;
         14. Receipt of any subcutaneous testosterone pellets within the last 6 months.&#xD;
&#xD;
         15. Inability to understand and provide written informed consent for the study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ranjith Ramasamy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Corona G, Rastrelli G, Maggi M. Diagnosis and treatment of late-onset hypogonadism: systematic review and meta-analysis of TRT outcomes. Best Pract Res Clin Endocrinol Metab. 2013 Aug;27(4):557-79. doi: 10.1016/j.beem.2013.05.002. Epub 2013 Jul 5.</citation>
    <PMID>24054931</PMID>
  </reference>
  <reference>
    <citation>Haring R, Volzke H, Steveling A, Krebs A, Felix SB, Schofl C, Dorr M, Nauck M, Wallaschofski H. Low serum testosterone levels are associated with increased risk of mortality in a population-based cohort of men aged 20-79. Eur Heart J. 2010 Jun;31(12):1494-501. doi: 10.1093/eurheartj/ehq009. Epub 2010 Feb 17.</citation>
    <PMID>20164245</PMID>
  </reference>
  <reference>
    <citation>Walker WH. Testosterone signaling and the regulation of spermatogenesis. Spermatogenesis. 2011 Apr;1(2):116-120. doi: 10.4161/spmg.1.2.16956.</citation>
    <PMID>22319659</PMID>
  </reference>
  <reference>
    <citation>Katznelson L, Finkelstein JS, Schoenfeld DA, Rosenthal DI, Anderson EJ, Klibanski A. Increase in bone density and lean body mass during testosterone administration in men with acquired hypogonadism. J Clin Endocrinol Metab. 1996 Dec;81(12):4358-65. doi: 10.1210/jcem.81.12.8954042.</citation>
    <PMID>8954042</PMID>
  </reference>
  <reference>
    <citation>Finkelstein JS, Klibanski A, Neer RM, Greenspan SL, Rosenthal DI, Crowley WF Jr. Osteoporosis in men with idiopathic hypogonadotropic hypogonadism. Ann Intern Med. 1987 Mar;106(3):354-61. doi: 10.7326/0003-4819-106-3-.</citation>
    <PMID>3544993</PMID>
  </reference>
  <reference>
    <citation>Jockenhovel F, Vogel E, Reinhardt W, Reinwein D. Effects of various modes of androgen substitution therapy on erythropoiesis. Eur J Med Res. 1997 Jul 28;2(7):293-8.</citation>
    <PMID>9233903</PMID>
  </reference>
  <reference>
    <citation>Behre HM, Bohmeyer J, Nieschlag E. Prostate volume in testosterone-treated and untreated hypogonadal men in comparison to age-matched normal controls. Clin Endocrinol (Oxf). 1994 Mar;40(3):341-9. doi: 10.1111/j.1365-2265.1994.tb03929.x.</citation>
    <PMID>7514512</PMID>
  </reference>
  <reference>
    <citation>Davidson JM, Camargo CA, Smith ER. Effects of androgen on sexual behavior in hypogonadal men. J Clin Endocrinol Metab. 1979 Jun;48(6):955-8. doi: 10.1210/jcem-48-6-955.</citation>
    <PMID>447801</PMID>
  </reference>
  <reference>
    <citation>Snyder PJ, Peachey H, Berlin JA, Hannoush P, Haddad G, Dlewati A, Santanna J, Loh L, Lenrow DA, Holmes JH, Kapoor SC, Atkinson LE, Strom BL. Effects of testosterone replacement in hypogonadal men. J Clin Endocrinol Metab. 2000 Aug;85(8):2670-7. doi: 10.1210/jcem.85.8.6731.</citation>
    <PMID>10946864</PMID>
  </reference>
  <reference>
    <citation>Baillargeon J, Urban RJ, Ottenbacher KJ, Pierson KS, Goodwin JS. Trends in androgen prescribing in the United States, 2001 to 2011. JAMA Intern Med. 2013 Aug 12;173(15):1465-6. doi: 10.1001/jamainternmed.2013.6895. No abstract available. Erratum In: JAMA Intern Med. 2013 Aug 12;173(15):1477.</citation>
    <PMID>23939517</PMID>
  </reference>
  <reference>
    <citation>Ullah MI, Riche DM, Koch CA. Transdermal testosterone replacement therapy in men. Drug Des Devel Ther. 2014 Jan 9;8:101-12. doi: 10.2147/DDDT.S43475. eCollection 2014.</citation>
    <PMID>24470750</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Ranjith Ramasamy, MD</investigator_full_name>
    <investigator_title>Director of Male Fertility and Andrology, University of Miami</investigator_title>
  </responsible_party>
  <keyword>Low T</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypogonadism</mesh_term>
    <mesh_term>Eunuchism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methyltestosterone</mesh_term>
    <mesh_term>Testosterone</mesh_term>
    <mesh_term>Testosterone undecanoate</mesh_term>
    <mesh_term>Testosterone enanthate</mesh_term>
    <mesh_term>Testosterone 17 beta-cypionate</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/NCT04439799
org study id: 20200201
nct id: NCT04439799
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to evaluate changes in vascular parameters and the prevalence of
      side effects in subjects receiving 1 cc (200mg) every 2 weeks intramuscular (IM) of
      Testosterone Cypionate versus subjects receiving 11mg three times daily (TID) Natesto to
      participant with clinical hypogonadism.
Administration of exogenous testosterone as efficacious treatment for male hypogonadism has
      been part of medical practice for more than 50 years. Testosterone replacement therapy (TRT)
      is becoming more widely available and has seen a greater than three-fold increase in use in
      men 40 years and older. Current delivery systems of TRT include transdermal gels and patches,
      intranasal gels (currently marketed as Natesto), injection therapy, and long acting
      subcutaneous pellets.

      Natesto is a short-acting formulation of testosterone delivered intranasally to men diagnosed
      with low T. This has the potential to avoid side effects related to TRT that are commonly
      seen with other delivery methods, namely polycythemia, acne, male-pattern hair loss,
      azoospermia and hyperestrogenemia.

      Testosterone Cypionate injections are the most common form of TRT in the USA. Testosterone
      Cypionate has many reported side effects, the most common being polycythemia, gynecomastia,
      hair loss, acne, decreased spermatogenesis, and testicular atrophy. In a multicenter
      retrospective study, it has been shown that the prevalence of polycythemia in men on
      testosterone replacement (injections) was 11.2%. In this study, we will compare hematocrit
      changes caused by treatment with Testosterone Cypionate and Natesto in a parallel arm,
      randomized study. To date, there have been no direct head-to-haed comparisons of these
      formulations.

      We hypothesize that the short-acting pharmacokinetics of Natesto more closely resembles the
      natural pulsatility of testosterone and therefore can avoid side effects traditionally seen
      in long-acting, exogenous testosterone formulations
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Hematocrit (Hct) levels.
time frame: Baseline, 4 months
description: Changes in serum Hct levels will be assessed in %
measure: Change in gonadotropin levels
time frame: Baseline, 4 months
description: Change in serum gonadotropin levels including Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH), both assessed in mIU/mL.
measure: Change in hormone levels
time frame: Baseline, 4 months
description: Change in serum hormone levels including Testosterone, 17 -Hydroxyprogesterone (17-OHP) and Dihydrotestosterone (DHT), all assessed in ng/dL.
measure: Change in PSA levels
time frame: Baseline, 4 months
description: Change in serum Prostate Specific Antigen (PSA) levels will be assessed in ng/mL.
measure: Change in estrogen levels
time frame: Baseline, 4 months
description: Change in serum estrogen levels will be assessed in pg/mL.
measure: Change in Testicular Volume
time frame: baseline, 4 months
description: changes in testicular volume will be assessed in cc. An orchidometer will be the instrument of assessment during physical exam.
measure: Changes in IIEF score
time frame: Baseline, 4 months
description: The International Index of Erectile Function (IIEF)-15 is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function.
measure: 8. Change in SF-15 Erectile Function Domain Scores
time frame: Baseline, 4 months
description: The Short Form (SF)-15 Questionnaire Erectile Function domain has a total score ranging from 0-25 with the higher score indicating better erectile function.
measure: Change in SF-15 Intercourse Satisfaction Domain Scores
time frame: Baseline, 4 months
description: The SF-15 Questionnaire Intercourse Satisfaction domain has a total score ranging from 0-15 with the higher score indicating better intercourse satisfaction.
measure: Change in SF-15 Questionnaire Scores
time frame: Baseline, 4 months
description: The SF-15 Questionnaire Orgasmic Function, Sexual Desire and Overall Satisfaction domains each has a total score ranging from 0-10 with the higher score indicating better outcomes.
arm group label: Testosterone Cypionate Group
arm group type: Active Comparator
description: Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months
arm group label: Natesto Group
arm group type: Active Comparator
description: Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.
intervention type: Drug
intervention name: Testosterone Cypionate 200 MG/ML
description: Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
arm group label: Testosterone Cypionate Group
intervention type: Drug
intervention name: Intranasal Testosterone
description: Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as two or three daily doses (5.5 mg per nostril, 11.0 mg single dose) for 4 consecutive months,
arm group label: Natesto Group
other name: Natesto
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ranjith Ramasamy, MD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
citation: Corona G, Rastrelli G, Maggi M. Diagnosis and treatment of late-onset hypogonadism: systematic review and meta-analysis of TRT outcomes. Best Pract Res Clin Endocrinol Metab. 2013 Aug;27(4):557-79. doi: 10.1016/j.beem.2013.05.002. Epub 2013 Jul 5.
PMID: 24054931
citation: Haring R, Volzke H, Steveling A, Krebs A, Felix SB, Schofl C, Dorr M, Nauck M, Wallaschofski H. Low serum testosterone levels are associated with increased risk of mortality in a population-based cohort of men aged 20-79. Eur Heart J. 2010 Jun;31(12):1494-501. doi: 10.1093/eurheartj/ehq009. Epub 2010 Feb 17.
PMID: 20164245
citation: Walker WH. Testosterone signaling and the regulation of spermatogenesis. Spermatogenesis. 2011 Apr;1(2):116-120. doi: 10.4161/spmg.1.2.16956.
PMID: 22319659
citation: Katznelson L, Finkelstein JS, Schoenfeld DA, Rosenthal DI, Anderson EJ, Klibanski A. Increase in bone density and lean body mass during testosterone administration in men with acquired hypogonadism. J Clin Endocrinol Metab. 1996 Dec;81(12):4358-65. doi: 10.1210/jcem.81.12.8954042.
PMID: 8954042
citation: Finkelstein JS, Klibanski A, Neer RM, Greenspan SL, Rosenthal DI, Crowley WF Jr. Osteoporosis in men with idiopathic hypogonadotropic hypogonadism. Ann Intern Med. 1987 Mar;106(3):354-61. doi: 10.7326/0003-4819-106-3-.
PMID: 3544993
citation: Jockenhovel F, Vogel E, Reinhardt W, Reinwein D. Effects of various modes of androgen substitution therapy on erythropoiesis. Eur J Med Res. 1997 Jul 28;2(7):293-8.
PMID: 9233903
citation: Behre HM, Bohmeyer J, Nieschlag E. Prostate volume in testosterone-treated and untreated hypogonadal men in comparison to age-matched normal controls. Clin Endocrinol (Oxf). 1994 Mar;40(3):341-9. doi: 10.1111/j.1365-2265.1994.tb03929.x.
PMID: 7514512
citation: Davidson JM, Camargo CA, Smith ER. Effects of androgen on sexual behavior in hypogonadal men. J Clin Endocrinol Metab. 1979 Jun;48(6):955-8. doi: 10.1210/jcem-48-6-955.
PMID: 447801
citation: Snyder PJ, Peachey H, Berlin JA, Hannoush P, Haddad G, Dlewati A, Santanna J, Loh L, Lenrow DA, Holmes JH, Kapoor SC, Atkinson LE, Strom BL. Effects of testosterone replacement in hypogonadal men. J Clin Endocrinol Metab. 2000 Aug;85(8):2670-7. doi: 10.1210/jcem.85.8.6731.
PMID: 10946864
citation: Baillargeon J, Urban RJ, Ottenbacher KJ, Pierson KS, Goodwin JS. Trends in androgen prescribing in the United States, 2001 to 2011. JAMA Intern Med. 2013 Aug 12;173(15):1465-6. doi: 10.1001/jamainternmed.2013.6895. No abstract available. Erratum In: JAMA Intern Med. 2013 Aug 12;173(15):1477.
PMID: 23939517
citation: Ullah MI, Riche DM, Koch CA. Transdermal testosterone replacement therapy in men. Drug Des Devel Ther. 2014 Jan 9;8:101-12. doi: 10.2147/DDDT.S43475. eCollection 2014.
PMID: 24470750
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Ranjith Ramasamy, MD
investigator title: Director of Male Fertility and Andrology, University of Miami
mesh term: Hypogonadism
mesh term: Eunuchism
mesh term: Methyltestosterone
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
mesh term: Testosterone 17 beta-cypionate
sharing ipd: No