<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/NCT03834610</url>
  </required_header>
  <id_info>
    <org_study_id>L-arginine</org_study_id>
    <nct_id>NCT03834610</nct_id>
  </id_info>
  <brief_title>Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction</brief_title>
  <official_title>Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction: A Double-blinded Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aswan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aswan University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tadalafil is an effective oral therapy in erectile dysfunction. L-arginine is a pro drug that&#xD;
      increase the level of nitrous oxide in the smooth muscles so can increase the strength and&#xD;
      duration of erection. this clinical trials compare the daily oral L-arginine plus tadalafil&#xD;
      in treatment of erectile dysfunction in diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</primary_completion_date>
  <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>International Index of Erectile Function score (IIEF-5) improvement after treatment. IIEF-5 score of 22-25: No erectile dysfunction (ED), 17-21: Mild ED, 12-16: Mild to moderate ED, 8-11: Moderate ED, 5-7: Severe ED.</measure>
    <time_frame>8 weeks of treatment</time_frame>
    <description>Efficacy of oral L-arginine 5 g plus oral tadalafil 10 mg in treatment of erectile dysfunction in diabetic patients is evaluated by International Index of Erectile Function score (IIEF-5).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Increase in Serum Total testosterone level in (nmol/L) after treatment.</measure>
    <time_frame>8 weeks of treatment</time_frame>
    <description>Measurement of total testosterone level in (nmol/L) improvement after treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in Penile Doppler parameters after treatment including peak systolic velocity in (cm/sec), end diastolic volume in (cm/sec) and resistive index (RI) that = (peak systolic velocity - end diastolic velocity ) / peak systolic velocity.</measure>
    <time_frame>8 weeks of treatment</time_frame>
    <description>Measurement of penile doppler parameters improvement after treatment peak systolic velocity in (cm/sec), end diastolic volume in (cm/sec) and resistive index (RI).</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>L-arginine 5 gm oral caps</intervention_name>
    <description>oral L-arginine 5 gm daily for 8 weeks</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tadalafil 10 MG</intervention_name>
    <description>oral daily tadalafil 10mg for 8 weeks</description>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>serum testosterone level</intervention_name>
    <description>measurement of serum testosterone level</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>HbA1C</intervention_name>
    <description>measurement of HbA1C levels</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>penile doppler</intervention_name>
    <description>penile doppler to measure the degree of erection and penile vasculature</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with type 2 DM&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of pelvic trauma, major pelvic surgical intervention,&#xD;
             hypogonadism, hyperprolactinemia, hypertension, chronic prostatitis, chronic liver&#xD;
             disease, smokers, history of chronic intake of CNS or anti-androgen drugs and patients&#xD;
             with Peyronie's Disease or any fibrotic anomalies&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>56 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moustafa M El Taieb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aswan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aswan University Hospital</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aswan University Hospital</investigator_affiliation>
    <investigator_full_name>Moustafa A. El Taieb</investigator_full_name>
    <investigator_title>Ass. Prof. of Dermatology, Venereology and Andrology</investigator_title>
  </responsible_party>
  <keyword>Erectile dysfunction</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Tadaladil</keyword>
  <keyword>L-arginine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tadalafil</mesh_term>
    <mesh_term>Testosterone</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/NCT03834610
org study id: L-arginine
nct id: NCT03834610
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Tadalafil is an effective oral therapy in erectile dysfunction. L-arginine is a pro drug that
      increase the level of nitrous oxide in the smooth muscles so can increase the strength and
      duration of erection. this clinical trials compare the daily oral L-arginine plus tadalafil
      in treatment of erectile dysfunction in diabetic patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: International Index of Erectile Function score (IIEF-5) improvement after treatment. IIEF-5 score of 22-25: No erectile dysfunction (ED), 17-21: Mild ED, 12-16: Mild to moderate ED, 8-11: Moderate ED, 5-7: Severe ED.
time frame: 8 weeks of treatment
description: Efficacy of oral L-arginine 5 g plus oral tadalafil 10 mg in treatment of erectile dysfunction in diabetic patients is evaluated by International Index of Erectile Function score (IIEF-5).
measure: Increase in Serum Total testosterone level in (nmol/L) after treatment.
time frame: 8 weeks of treatment
description: Measurement of total testosterone level in (nmol/L) improvement after treatment
measure: Improvement in Penile Doppler parameters after treatment including peak systolic velocity in (cm/sec), end diastolic volume in (cm/sec) and resistive index (RI) that = (peak systolic velocity - end diastolic velocity ) / peak systolic velocity.
time frame: 8 weeks of treatment
description: Measurement of penile doppler parameters improvement after treatment peak systolic velocity in (cm/sec), end diastolic volume in (cm/sec) and resistive index (RI).
arm group label: Group A
arm group type: Active Comparator
description: receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler
arm group label: Group B
arm group type: Active Comparator
description: receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
arm group label: Group C
arm group type: Active Comparator
description: receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
arm group label: Group D
arm group type: Placebo Comparator
description: receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler
intervention type: Drug
intervention name: L-arginine 5 gm oral caps
description: oral L-arginine 5 gm daily for 8 weeks
arm group label: Group A
arm group label: Group C
intervention type: Drug
intervention name: Tadalafil 10 MG
description: oral daily tadalafil 10mg for 8 weeks
arm group label: Group B
arm group label: Group C
intervention type: Diagnostic Test
intervention name: serum testosterone level
description: measurement of serum testosterone level
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
intervention type: Diagnostic Test
intervention name: HbA1C
description: measurement of HbA1C levels
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
intervention type: Device
intervention name: penile doppler
description: penile doppler to measure the degree of erection and penile vasculature
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
criteria: 
gender: Male
minimum age: 35 Years
maximum age: 56 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Moustafa M El Taieb, MD
role: Principal Investigator
affiliation: Aswan University Hospital
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: Moustafa A. El Taieb
investigator title: Ass. Prof. of Dermatology, Venereology and Andrology
mesh term: Erectile Dysfunction
mesh term: Tadalafil
mesh term: Testosterone
sharing ipd: No