<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/NCT03039504</url>
  </required_header>
  <id_info>
    <org_study_id>Potensa02-2017</org_study_id>
    <nct_id>NCT03039504</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction</brief_title>
  <official_title>Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Research Center, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Research Center, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double blind, placebo-controlled, comparative, prospective study&#xD;
      (clinical evaluation) of the effectiveness and safety of dietary supplement Potensa in men&#xD;
      with mild to moderate erectile dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Actual">June 28, 2017</completion_date>
  <primary_completion_date type="Actual">June 28, 2017</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the International Index of Erectile Function (IIEF) score</measure>
    <time_frame>Baseline - 30 days</time_frame>
    <description>Self reported erectile function; higher score indicates less dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the International Index of Erectile Function (IIEF) score</measure>
    <time_frame>Baseline - 60 days</time_frame>
    <description>Self reported erectile function; higher score indicates less dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the International Index of Erectile Function (IIEF) score</measure>
    <time_frame>Baseline - 90 days</time_frame>
    <description>Self reported erectile function; higher score indicates less dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the Aging Male Symptome Scale (AMS) score</measure>
    <time_frame>Baseline - 30 days</time_frame>
    <description>Self reported symptoms; lower score indicates fewer/lesser symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the Aging Male Symptome Scale (AMS) score</measure>
    <time_frame>Baseline - 60 days</time_frame>
    <description>Self reported symptoms; lower score indicates fewer/lesser symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the Aging Male Symptome Scale (AMS) score</measure>
    <time_frame>Baseline - 90 days</time_frame>
    <description>Self reported symptoms; lower score indicates fewer/lesser symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the Spielberger-Hanin anxiety test</measure>
    <time_frame>Baseline - 30 days</time_frame>
    <description>Self-administered questionnaire; higher score indicates more anxiety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the Spielberger-Hanin anxiety test</measure>
    <time_frame>Baseline - 60 days</time_frame>
    <description>Self-administered questionnaire; higher score indicates more anxiety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the Spielberger-Hanin anxiety test</measure>
    <time_frame>Baseline - 90 days</time_frame>
    <description>Self-administered questionnaire; higher score indicates more anxiety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in testosterone levels</measure>
    <time_frame>Baseline - 30 days</time_frame>
    <description>Blood testosterone levels, pg/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in testosterone levels</measure>
    <time_frame>Baseline - 60 days</time_frame>
    <description>Blood testosterone levels, pg/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in testosterone levels</measure>
    <time_frame>Baseline - 90 days</time_frame>
    <description>Blood testosterone levels, pg/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in follicle stimulating hormone (FSH) levels</measure>
    <time_frame>Baseline - 30 days</time_frame>
    <description>Blood FSH levels, mIU/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in follicle stimulating hormone (FSH) levels</measure>
    <time_frame>Baseline - 60 days</time_frame>
    <description>Blood FSH levels, mIU/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in follicle stimulating hormone (FSH) levels</measure>
    <time_frame>Baseline - 90 days</time_frame>
    <description>Blood FSH levels, mIU/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in luteinizing hormone (LH) levels</measure>
    <time_frame>Baseline - 30 days</time_frame>
    <description>Blood LH levels, mIU/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in luteinizing hormone (LH) levels</measure>
    <time_frame>Baseline - 60 days</time_frame>
    <description>Blood LH levels, mIU/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in luteinizing hormone (LH) levels</measure>
    <time_frame>Baseline - 90 days</time_frame>
    <description>Blood LH levels, mIU/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Sex Hormone Binding Globulin (SHBG) levels</measure>
    <time_frame>Baseline - 30 days</time_frame>
    <description>Blood SHBG levels, nmol/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Sex Hormone Binding Globulin (SHBG) levels</measure>
    <time_frame>Baseline - 60 days</time_frame>
    <description>Blood SHBG levels, nmol/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Sex Hormone Binding Globulin (SHBG) levels</measure>
    <time_frame>Baseline - 90 days</time_frame>
    <description>Blood SHBG levels, nmol/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in inhibin B levels</measure>
    <time_frame>Baseline - 90 days</time_frame>
    <description>Blood inhibin B levels, ng/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in homocystein levels</measure>
    <time_frame>Baseline - 90 days</time_frame>
    <description>Blood homocystein levels, umol/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Baseline - 90 days</time_frame>
    <description>Based on the results of Spielberger-Hanin anxiety test (score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Baseline - 90 days</time_frame>
    <description>Based on the results of International Index of Erectile Function (IIEF) test (score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Baseline - 90 days</time_frame>
    <description>Based on the results of Aging Male Symptoms (AMS) test (score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive dynamics of the primary endpoints</measure>
    <time_frame>30th, 60th, 90th days</time_frame>
    <description>Percent of patients corresponding to the primary endpoints with positive dynamics</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Potensa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>succinate-based dietary supplement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Potensa, a succinate-based dietary supplement</intervention_name>
    <description>Potensa - a dietary supplement: 4 capsules (2 white 200mg each and 2 blue 200 mg each) once a day with a meal or immediately after a meal, preferably after breakfast, for 3 months.</description>
    <arm_group_label>Potensa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo: 4 capsules (2 white 200mg each and 2 blue 200 mg each) once a day with a meal or immediately after a meal, preferably after breakfast, for 3 months.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men, 18 years of age or older;&#xD;
&#xD;
          -  Patients diagnosed with &quot;erectile dysfunctions&quot; of various pathogenesis, typical form&#xD;
             without complications;&#xD;
&#xD;
          -  Ability to read and understand informed consent in order to participate in the study;&#xD;
&#xD;
          -  Ability to follow study's conditions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oncological illnesses, except those in complete remission for at least 5 years;&#xD;
&#xD;
          -  Conditions that may require emergency or planned hospitalization in the next 6 months;&#xD;
&#xD;
          -  Extragenital endocrine conditions (hormonally active) (thyroid, adrenal glands,&#xD;
             pituitary, hypothalamus);&#xD;
&#xD;
          -  Surgeries on sex organ within 1 year of the screening;&#xD;
&#xD;
          -  Any surgeries within 3 months of the screening;&#xD;
&#xD;
          -  Psychiatric illnesses;&#xD;
&#xD;
          -  Diabetes mellitus;&#xD;
&#xD;
          -  Cryptorchidism&#xD;
&#xD;
          -  Taking other dietary supplements that can affect erectile dysfunction within 1 month&#xD;
             of participating in the study;&#xD;
&#xD;
          -  High risk of non-compliance.&#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>Evgenii A Efremov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>N.A. Lopatkin Urology and Interventional Radiology Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>N.A. Lopatkin Urology and Interventional Radiology Research Center</name>
      <address>
        <city>Moscow</city>
        <zip>105425</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ryazan State Medical University named after academician I.P. Pavlov</name>
      <address>
        <city>Ryazan'</city>
        <zip>390026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>June 30, 2017</last_update_submitted>
  <last_update_submitted_qc>June 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Succinates</keyword>
  <keyword>Dietary supplement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_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/NCT03039504
org study id: Potensa02-2017
nct id: NCT03039504
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized, double blind, placebo-controlled, comparative, prospective study
      (clinical evaluation) of the effectiveness and safety of dietary supplement Potensa in men
      with mild to moderate erectile dysfunction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change from baseline in the International Index of Erectile Function (IIEF) score
time frame: Baseline - 30 days
description: Self reported erectile function; higher score indicates less dysfunction
measure: Change from baseline in the International Index of Erectile Function (IIEF) score
time frame: Baseline - 60 days
description: Self reported erectile function; higher score indicates less dysfunction
measure: Change from baseline in the International Index of Erectile Function (IIEF) score
time frame: Baseline - 90 days
description: Self reported erectile function; higher score indicates less dysfunction
measure: Change from baseline in the Aging Male Symptome Scale (AMS) score
time frame: Baseline - 30 days
description: Self reported symptoms; lower score indicates fewer/lesser symptoms
measure: Change from baseline in the Aging Male Symptome Scale (AMS) score
time frame: Baseline - 60 days
description: Self reported symptoms; lower score indicates fewer/lesser symptoms
measure: Change from baseline in the Aging Male Symptome Scale (AMS) score
time frame: Baseline - 90 days
description: Self reported symptoms; lower score indicates fewer/lesser symptoms
measure: Change from baseline in the Spielberger-Hanin anxiety test
time frame: Baseline - 30 days
description: Self-administered questionnaire; higher score indicates more anxiety
measure: Change from baseline in the Spielberger-Hanin anxiety test
time frame: Baseline - 60 days
description: Self-administered questionnaire; higher score indicates more anxiety
measure: Change from baseline in the Spielberger-Hanin anxiety test
time frame: Baseline - 90 days
description: Self-administered questionnaire; higher score indicates more anxiety
measure: Change from baseline in testosterone levels
time frame: Baseline - 30 days
description: Blood testosterone levels, pg/ml
measure: Change from baseline in testosterone levels
time frame: Baseline - 60 days
description: Blood testosterone levels, pg/ml
measure: Change from baseline in testosterone levels
time frame: Baseline - 90 days
description: Blood testosterone levels, pg/ml
measure: Change from baseline in follicle stimulating hormone (FSH) levels
time frame: Baseline - 30 days
description: Blood FSH levels, mIU/ml
measure: Change from baseline in follicle stimulating hormone (FSH) levels
time frame: Baseline - 60 days
description: Blood FSH levels, mIU/ml
measure: Change from baseline in follicle stimulating hormone (FSH) levels
time frame: Baseline - 90 days
description: Blood FSH levels, mIU/ml
measure: Change from baseline in luteinizing hormone (LH) levels
time frame: Baseline - 30 days
description: Blood LH levels, mIU/ml
measure: Change from baseline in luteinizing hormone (LH) levels
time frame: Baseline - 60 days
description: Blood LH levels, mIU/ml
measure: Change from baseline in luteinizing hormone (LH) levels
time frame: Baseline - 90 days
description: Blood LH levels, mIU/ml
measure: Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
time frame: Baseline - 30 days
description: Blood SHBG levels, nmol/L
measure: Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
time frame: Baseline - 60 days
description: Blood SHBG levels, nmol/L
measure: Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
time frame: Baseline - 90 days
description: Blood SHBG levels, nmol/L
measure: Change from baseline in inhibin B levels
time frame: Baseline - 90 days
description: Blood inhibin B levels, ng/L
measure: Change from baseline in homocystein levels
time frame: Baseline - 90 days
description: Blood homocystein levels, umol/L
measure: Quality of life
time frame: Baseline - 90 days
description: Based on the results of Spielberger-Hanin anxiety test (score).
measure: Quality of life
time frame: Baseline - 90 days
description: Based on the results of International Index of Erectile Function (IIEF) test (score)
measure: Quality of life
time frame: Baseline - 90 days
description: Based on the results of Aging Male Symptoms (AMS) test (score)
measure: Positive dynamics of the primary endpoints
time frame: 30th, 60th, 90th days
description: Percent of patients corresponding to the primary endpoints with positive dynamics
arm group label: Potensa
arm group type: Experimental
description: succinate-based dietary supplement
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo
intervention type: Dietary Supplement
intervention name: Potensa, a succinate-based dietary supplement
description: Potensa - a dietary supplement: 4 capsules (2 white 200mg each and 2 blue 200 mg each) once a day with a meal or immediately after a meal, preferably after breakfast, for 3 months.
arm group label: Potensa
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo: 4 capsules (2 white 200mg each and 2 blue 200 mg each) once a day with a meal or immediately after a meal, preferably after breakfast, for 3 months.
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evgenii A Efremov, MD
role: Principal Investigator
affiliation: N.A. Lopatkin Urology and Interventional Radiology Research Center
facility: 
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Erectile Dysfunction
sharing ipd: No