<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/NCT03033537</url>
  </required_header>
  <id_info>
    <org_study_id>2016</org_study_id>
    <nct_id>NCT03033537</nct_id>
  </id_info>
  <brief_title>Intracavernosal Injection of Papaverine/Verapamil Versus Papaverine/Phentolamine in Erectile Dysfunction</brief_title>
  <official_title>Intracavernosal Injection of Papaverine/Verapamil Versus Papaverine/Phentolamine in Erectile Dysfunction: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adam International Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Adam International 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>
      Introduction: Erectile dysfunction is a common condition with a significant effect on quality&#xD;
      of life. Verapamil is calcium channel blocker of the phenyl alkylamine class which relaxes&#xD;
      the tone of the smooth muscles lining blood vessels, leading to their dilatation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: Evaluating the effect of intracavernosal injection of (Papaverine + Verapamil) and&#xD;
      comparing it with (Papaverine + Phentolamine) in patients with erectile dysfunction.&#xD;
&#xD;
      Patients and methods: Each one of the 20 erectile dysfunction patients was subjected to&#xD;
      intracavernosal injection with (30mg Papaverine + 1mg Phentolamine), where penile duplex &amp;&#xD;
      clinical evaluation was carried out followed by a wash out interval of 2 weeks after which&#xD;
      each patient was subjected to the exact previous procedures using (30 mg Papaverine + 5 mg&#xD;
      Verapamil).&#xD;
&#xD;
      Keywords: Erectile dysfunction - Intracavernosal injection - Penile duplex - Phentolamine -&#xD;
      Verapamil.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Actual">January 20, 2016</completion_date>
  <primary_completion_date type="Actual">January 1, 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>IIEF5</measure>
    <time_frame>6 months</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Verapamil</arm_group_label>
    <description>Intracavernosal injection of Verapamil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phentolamine</arm_group_label>
    <description>Intracavernosal injection of Phentolamine to treat erectile dysfunction for a period of 2 wweks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Verapamil</intervention_name>
    <description>Local treatment of erectile dysfunction</description>
    <arm_group_label>Phentolamine</arm_group_label>
    <arm_group_label>Verapamil</arm_group_label>
    <other_name>Calcium Channel Blocker</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Males complaining of erectile dysfunction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Married male patients suffering from erectile dysfunction and scheduled for&#xD;
             intracavernosal injection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Responders to PDE5-inhibitors; congenital or acquired penile anomalies; uncontrolled&#xD;
             medical conditions or known hypersensitivity to verapamil; Peyronie's disease and any&#xD;
             known bleeding or coagulation disorders.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Adam International Hospital</investigator_affiliation>
    <investigator_full_name>Ahmad Raef Sadek</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <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>Verapamil</mesh_term>
    <mesh_term>Calcium Channel Blockers</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/NCT03033537
org study id: 2016
nct id: NCT03033537
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Introduction: Erectile dysfunction is a common condition with a significant effect on quality
      of life. Verapamil is calcium channel blocker of the phenyl alkylamine class which relaxes
      the tone of the smooth muscles lining blood vessels, leading to their dilatation.
Objective: Evaluating the effect of intracavernosal injection of (Papaverine + Verapamil) and
      comparing it with (Papaverine + Phentolamine) in patients with erectile dysfunction.

      Patients and methods: Each one of the 20 erectile dysfunction patients was subjected to
      intracavernosal injection with (30mg Papaverine + 1mg Phentolamine), where penile duplex &
      clinical evaluation was carried out followed by a wash out interval of 2 weeks after which
      each patient was subjected to the exact previous procedures using (30 mg Papaverine + 5 mg
      Verapamil).

      Keywords: Erectile dysfunction - Intracavernosal injection - Penile duplex - Phentolamine -
      Verapamil.
observational model: Case-Crossover
time perspective: Prospective
measure: IIEF5
time frame: 6 months
description: Questionnaire
arm group label: Verapamil
description: Intracavernosal injection of Verapamil
arm group label: Phentolamine
description: Intracavernosal injection of Phentolamine to treat erectile dysfunction for a period of 2 wweks
intervention type: Drug
intervention name: Verapamil
description: Local treatment of erectile dysfunction
arm group label: Phentolamine
arm group label: Verapamil
other name: Calcium Channel Blocker
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Adam International Hospital
investigator full name: Ahmad Raef Sadek
investigator title: Dr.
mesh term: Erectile Dysfunction
mesh term: Verapamil
mesh term: Calcium Channel Blockers
sharing ipd: No