<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/NCT03281187</url>
  </required_header>
  <id_info>
    <org_study_id>TESFBM0717NA-III</org_study_id>
    <nct_id>NCT03281187</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Testosterone Nasal Gel for Treating Hypogonadism in Men.</brief_title>
  <official_title>A Randomized, Parallel, Double-dummy, Multi-center Phase III Study for Evaluation of Efficacy and Safety of Nasotestt Compared to Androgel Treating Hypogonadism in Male Research Participants.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FBM Industria Brasileira Ltda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Azidus Brasil Scientific Research and Development Ltda</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>FBM Industria Brasileira Ltda</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a phase III study for evaluation of Nasotestt efficacy compared to Androgel in the&#xD;
      treatment of male participants with hypogonadism condition (reduced levels of testosterone)&#xD;
      that have clinical indication of hormonal replacement with testosterone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This efficacy and safety study will evaluate the superiority of Nasotestt (nasal gel)&#xD;
      treatment compared to Androgel (topic gel) after 60 days of starting use. The efficacy&#xD;
      endpoint will be verified through the percentage of participants which presented at the end&#xD;
      of 60 days normalized levels of total testosterone (&lt;300 ng/dL to &gt;1050 ng/dL). Secondary&#xD;
      efficacy endpoints will be collected throughout the study through: evaluation of symptoms of&#xD;
      erectile dysfunction (The International Index of Erectile Function - IIEF), symptoms of&#xD;
      prostatic disease (International Prostate Symptom Score - IPSS), measurement of abdominal&#xD;
      perimeter and clinical global response to treatment (CGI-I questionnaire). As exploratory&#xD;
      investigation, the satisfaction/comfort of Nasotestt use will be assessed by a specific&#xD;
      questionnaire that will be applied to participants at the end of study. Safety evaluation&#xD;
      data will include report of all adverse events, including type, frequency, intensity,&#xD;
      seriousness, severity and action taken related to the investigational product of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 16, 2018</start_date>
  <completion_date type="Anticipated">January 13, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 12, 2018</primary_completion_date>
  <phase>Phase 3</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>
    <masking_description>Due to the differences on test and comparator product a double-dummy design will be used retaining the blind of the study. Therefore each participant will receive an active product and inactive medication (placebo).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Superiority Efficacy of Nasotestt comparing to Androgel on normalization of the blood testosterone levels</measure>
    <time_frame>60 days</time_frame>
    <description>The success of treatment will be evaluated through statistical comparison of percentage of participants that achieved normal blood testosterone levels after 60 days of use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of erectile dysfunction symptoms</measure>
    <time_frame>60 and 90 days after starting treatment.</time_frame>
    <description>Will be evaluated by statistical comparison between IIEF baseline values and results observed throughout study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of prostatic symptoms</measure>
    <time_frame>60 and 90 days after starting treatment.</time_frame>
    <description>Will be evaluated by statistical comparison between I-PSS baseline values and results observed throughout study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of abdominal perimeter</measure>
    <time_frame>60 and 90 days after starting treatment.</time_frame>
    <description>Will be evaluated by statistical comparison between baseline perimeter observed and other results obtained throughout study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Clinical Response to treatment</measure>
    <time_frame>90 days after starting treatment.</time_frame>
    <description>Will be assessed by a CGI - I questionnaire applied at the end of study. This instrument evaluate the improvement observed by physician throughout the study compared to condition observed at the baseline visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>During 120 days</time_frame>
    <description>Will be evaluated by periodic monitoring of adverse events, including changes in clinical laboratory parameters and vital signs occurred throughout the study.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Satisfaction and comfort of Nasotestt use</measure>
    <time_frame>After 120 days</time_frame>
    <description>Will be evaluated by specific questionnaire application at the end of study.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">228</enrollment>
  <condition>Hypogonadism</condition>
  <arm_group>
    <arm_group_label>Nasotestt 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm must administer one packet of Nasotestt 5 mg in each nostril (3 times a day - T.I.D) for 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Androgel 50 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this arm must administer one packet of Androgel 50 mg applied once daily to skin of shoulder for 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Androgel Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants must administer one packet of Androgel placebo applied once daily to skin of shoulder in addition to an experimental drug for 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasotestt Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants must administer one packet of Nasotestt Placebo in each nostril (3 times a day - T.I.D) in addition to an experimental drug for 60 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nasotestt 5 mg</intervention_name>
    <description>The 114 participants randomized to this arm must administer one packet of testosterone 5 mg nasal gel (Nasotestt) in each nostril 3 times a day for 60 days.</description>
    <arm_group_label>Androgel Placebo</arm_group_label>
    <arm_group_label>Nasotestt 5 mg</arm_group_label>
    <other_name>Test Group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Androgel 50 mg</intervention_name>
    <description>The 114 participants randomized to this arm must administer one packet of testosterone 50 mg topic gel (Androgel) applied once daily to skin of shoulders for 60 days.</description>
    <arm_group_label>Androgel 50 mg</arm_group_label>
    <arm_group_label>Nasotestt Placebo</arm_group_label>
    <other_name>Active Comparator Group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nasotestt Placebo</intervention_name>
    <description>The participants randomized to this arm must administer one packet of placebo testosterone nasal gel (Nasotestt Placebo) in each nostril 3 times a day in addition to an active drug for 60 days.</description>
    <arm_group_label>Androgel 50 mg</arm_group_label>
    <arm_group_label>Nasotestt Placebo</arm_group_label>
    <other_name>Placebo Test Group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Androgel Placebo</intervention_name>
    <description>The participants randomized to this arm must administer one packet of placebo testosterone topic gel (Androgel Placebo) applied once daily to skin of shoulders in addition to an active drug for 60 days.</description>
    <arm_group_label>Androgel Placebo</arm_group_label>
    <arm_group_label>Nasotestt 5 mg</arm_group_label>
    <other_name>Placebo Comparator Group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male research participant, aged 18 years or older, with BMI between 18.50 and 32.00&#xD;
             kg/m2;&#xD;
&#xD;
          2. To present symptomatic or asymptomatic hypogonadism and serum total morning&#xD;
             testosterone levels ≤ 300 ng / dL;&#xD;
&#xD;
          3. Laboratory evaluation of prostate specific antigen (PSA) levels within the normal&#xD;
             range established by the laboratory or with non clinically significant changes (NCS)&#xD;
             judged by the study Investigator;&#xD;
&#xD;
          4. Rhinoscopy and Glatzel mirror test normal or with changes that do not interfere with&#xD;
             nasal absorption of medication Test;&#xD;
&#xD;
          5. Present healthy skin in the region of Comparator product application (skin of the&#xD;
             shoulder).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnostic of prostatic and/or breast neoplasia;&#xD;
&#xD;
          2. PSA levels 4 ng/mL or higher, or 3 ng/mL or higher with elevated risk for prostatic&#xD;
             neoplasia development;&#xD;
&#xD;
          3. Treatment with estrogens, gonadotropin releasing hormone (GnRH), growth hormone (GH)&#xD;
             in the last 12 months;&#xD;
&#xD;
          4. Treatment with testosterone or any other androgen in the last two weeks (oral, buccal&#xD;
             and topic), four weeks (intramuscular) or twelve weeks (implant) that precede&#xD;
             randomization in the study;&#xD;
&#xD;
          5. Active rhinitis: allergic, seasonal, medicinal, vasomotor and atrophic;&#xD;
&#xD;
          6. Presence of grade II or III septum deviation (in any region of the nasal septum) and /&#xD;
             or presence of nasal polyps or other conditions that determine nasal obstruction;&#xD;
&#xD;
          7. Hypersensibility of testosterone as well as to components present in the formulation&#xD;
             of drugs.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alessandro Silva, Director</last_name>
    <role>Study Director</role>
    <affiliation>FBM Indústria Farmacêutica Ltda.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maxuel Monteiro, Regulatory</last_name>
    <phone>+55(62)3333-3500</phone>
    <phone_ext>3612</phone_ext>
    <email>maxuel.monteiro@fbmfarma.com.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Luciana Ferrara, CRO</last_name>
    <phone>+55(19)3829-6160</phone>
    <email>luciana.ferrara@azidusbrasil.com.br</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 18, 2017</last_update_submitted>
  <last_update_submitted_qc>September 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hormonal reposition, Testosterone nasal, Nasotestt</keyword>
  <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>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>Undecided</sharing_ipd>
    <ipd_description>It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data wil become public.</ipd_description>
  </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/NCT03281187
org study id: TESFBM0717NA-III
nct id: NCT03281187
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a phase III study for evaluation of Nasotestt efficacy compared to Androgel in the
      treatment of male participants with hypogonadism condition (reduced levels of testosterone)
      that have clinical indication of hormonal replacement with testosterone.
This efficacy and safety study will evaluate the superiority of Nasotestt (nasal gel)
      treatment compared to Androgel (topic gel) after 60 days of starting use. The efficacy
      endpoint will be verified through the percentage of participants which presented at the end
      of 60 days normalized levels of total testosterone (<300 ng/dL to >1050 ng/dL). Secondary
      efficacy endpoints will be collected throughout the study through: evaluation of symptoms of
      erectile dysfunction (The International Index of Erectile Function - IIEF), symptoms of
      prostatic disease (International Prostate Symptom Score - IPSS), measurement of abdominal
      perimeter and clinical global response to treatment (CGI-I questionnaire). As exploratory
      investigation, the satisfaction/comfort of Nasotestt use will be assessed by a specific
      questionnaire that will be applied to participants at the end of study. Safety evaluation
      data will include report of all adverse events, including type, frequency, intensity,
      seriousness, severity and action taken related to the investigational product of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Due to the differences on test and comparator product a double-dummy design will be used retaining the blind of the study. Therefore each participant will receive an active product and inactive medication (placebo).
measure: Superiority Efficacy of Nasotestt comparing to Androgel on normalization of the blood testosterone levels
time frame: 60 days
description: The success of treatment will be evaluated through statistical comparison of percentage of participants that achieved normal blood testosterone levels after 60 days of use.
measure: Improvement of erectile dysfunction symptoms
time frame: 60 and 90 days after starting treatment.
description: Will be evaluated by statistical comparison between IIEF baseline values and results observed throughout study.
measure: Improvement of prostatic symptoms
time frame: 60 and 90 days after starting treatment.
description: Will be evaluated by statistical comparison between I-PSS baseline values and results observed throughout study.
measure: Improvement of abdominal perimeter
time frame: 60 and 90 days after starting treatment.
description: Will be evaluated by statistical comparison between baseline perimeter observed and other results obtained throughout study.
measure: Global Clinical Response to treatment
time frame: 90 days after starting treatment.
description: Will be assessed by a CGI - I questionnaire applied at the end of study. This instrument evaluate the improvement observed by physician throughout the study compared to condition observed at the baseline visit.
measure: Incidence of adverse events
time frame: During 120 days
description: Will be evaluated by periodic monitoring of adverse events, including changes in clinical laboratory parameters and vital signs occurred throughout the study.
measure: Satisfaction and comfort of Nasotestt use
time frame: After 120 days
description: Will be evaluated by specific questionnaire application at the end of study.
arm group label: Nasotestt 5 mg
arm group type: Experimental
description: Participants randomized to this arm must administer one packet of Nasotestt 5 mg in each nostril (3 times a day - T.I.D) for 60 days.
arm group label: Androgel 50 mg
arm group type: Active Comparator
description: Participants randomized to this arm must administer one packet of Androgel 50 mg applied once daily to skin of shoulder for 60 days.
arm group label: Androgel Placebo
arm group type: Placebo Comparator
description: Participants must administer one packet of Androgel placebo applied once daily to skin of shoulder in addition to an experimental drug for 60 days.
arm group label: Nasotestt Placebo
arm group type: Placebo Comparator
description: Participants must administer one packet of Nasotestt Placebo in each nostril (3 times a day - T.I.D) in addition to an experimental drug for 60 days.
intervention type: Drug
intervention name: Nasotestt 5 mg
description: The 114 participants randomized to this arm must administer one packet of testosterone 5 mg nasal gel (Nasotestt) in each nostril 3 times a day for 60 days.
arm group label: Androgel Placebo
arm group label: Nasotestt 5 mg
other name: Test Group
intervention type: Drug
intervention name: Androgel 50 mg
description: The 114 participants randomized to this arm must administer one packet of testosterone 50 mg topic gel (Androgel) applied once daily to skin of shoulders for 60 days.
arm group label: Androgel 50 mg
arm group label: Nasotestt Placebo
other name: Active Comparator Group
intervention type: Other
intervention name: Nasotestt Placebo
description: The participants randomized to this arm must administer one packet of placebo testosterone nasal gel (Nasotestt Placebo) in each nostril 3 times a day in addition to an active drug for 60 days.
arm group label: Androgel 50 mg
arm group label: Nasotestt Placebo
other name: Placebo Test Group
intervention type: Other
intervention name: Androgel Placebo
description: The participants randomized to this arm must administer one packet of placebo testosterone topic gel (Androgel Placebo) applied once daily to skin of shoulders in addition to an active drug for 60 days.
arm group label: Androgel Placebo
arm group label: Nasotestt 5 mg
other name: Placebo Comparator Group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alessandro Silva, Director
role: Study Director
affiliation: FBM Indústria Farmacêutica Ltda.
last name: Maxuel Monteiro, Regulatory
phone: +55(62)3333-3500
phone ext: 3612
email: maxuel.monteiro@fbmfarma.com.br
last name: Luciana Ferrara, CRO
phone: +55(19)3829-6160
email: luciana.ferrara@azidusbrasil.com.br
responsible party type: Sponsor
mesh term: Hypogonadism
mesh term: Methyltestosterone
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
mesh term: Testosterone 17 beta-cypionate
sharing ipd: Undecided
ipd description: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data wil become public.