<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/NCT03813992</url>
  </required_header>
  <id_info>
    <org_study_id>FM57</org_study_id>
    <nct_id>NCT03813992</nct_id>
  </id_info>
  <brief_title>Clinical Trial Using Topically Applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction</brief_title>
  <official_title>A Phase III, Dose Ranging, Multi-centre, Randomised, Double Blind, Placebo Controlled, Home Use, Parallel Group Clinical Trial of Topically-applied Glyceryl Trinitrate for the Treatment of Erectile Dysfunction, With an Open Label Extension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Futura Medical Developments Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Futura Medical Developments Ltd.</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>
      To demonstrate the efficacy of various doses of MED2005 versus placebo in male patients with&#xD;
      clinically diagnosed erectile dysfunction, and to evaluate the long-term efficacy and safety&#xD;
      (12 months) of MED2005.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A phase III, dose-ranging, multi-centre, randomised, double-blind, placebo controlled ,&#xD;
      home-use, parallel group clinical trial of topically applied glyceryl trinitrate for the&#xD;
      treatment of erectile dysfunction with an open label extension&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">January 17, 2020</completion_date>
  <primary_completion_date type="Actual">July 21, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>International Index for Erectile Function (IIEF) Questionnaire</measure>
    <time_frame>Up to Week 64 of the study</time_frame>
    <description>A questionnaire containing 15 questions divided into 5 domains; erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sexual Encounter Profile (SEP) Questionnaire (Question 2)</measure>
    <time_frame>Up to Week 64 of the study</time_frame>
    <description>A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sexual Encounter Profile (SEP) Questionnaire (Question 3)</measure>
    <time_frame>Up to Week 64 of the study</time_frame>
    <description>A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-Esteem and Relationship (SEAR) Questionnaire</measure>
    <time_frame>Up to Week 12 of the study.</time_frame>
    <description>A questionnaire to support the validity and reliability for measuring sexual relationship satisfaction, satisfaction, confidence, and self-esteem in men with erectile dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment Questionnaire (GAQ)</measure>
    <time_frame>Up to Week 12 of the study.</time_frame>
    <description>A questionnaire that allows patients and their partners to rate (yes or no) an improvement in erectile function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Index for Erectile Function (IIEF) Questionnaire (additional domains)</measure>
    <time_frame>Up to Week 64 weeks of the study.</time_frame>
    <description>A questionnaire containing 15 questions divided into 5 domains; erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Encounter Profile (SEP) Questionnaire (Questions 1, 4 &amp; 5)</measure>
    <time_frame>Up to Week 64 of the study.</time_frame>
    <description>A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Encounter Profile (SEP) Questionnaire</measure>
    <time_frame>Up to Week 64 of the study</time_frame>
    <description>A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Severity (PGI-S)</measure>
    <time_frame>Up to Week 12 of the study.</time_frame>
    <description>A one item questionnaire to rate the severity of a patient's erectile dysfunction. This is a single-state 5-point categorical scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGI-C)</measure>
    <time_frame>Up to Week 12 of the study</time_frame>
    <description>A one item questionnaire to rate a perceived change in a patient's erectile function. This is a transitional 7-point categorical scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Onset and duration of action (erection) and erection hardness</measure>
    <time_frame>Up to Week 12 of the study</time_frame>
    <description>A questionnaire asking both the patient and the patient's partner about the onset and duration of action of the patient's erection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usage and application</measure>
    <time_frame>Up to Week 12 of the study</time_frame>
    <description>A questionnaire has 5 items to assess the usage and application of the investigation product.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1005</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>MED2005 0.2%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MED2005 0.2% w/w gel to deliver 0.6 mg dose of GTN applied topically prior to a sexual intercourse attempt</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MED2005 0.4%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MED2005 0.4% w/w gel to deliver 1.2 mg dose of GTN applied topically prior to a sexual intercourse attempt</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MED2005 0.6%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MED2005 0.6% w/w gel to deliver 1.8 mg dose of GTN applied topically prior to a sexual intercourse attempt</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo vehicle applied topically prior to a sexual intercourse attempt</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MED2005</intervention_name>
    <description>Topical Product</description>
    <arm_group_label>MED2005 0.2%</arm_group_label>
    <arm_group_label>MED2005 0.4%</arm_group_label>
    <arm_group_label>MED2005 0.6%</arm_group_label>
    <arm_group_label>Placebo vehicle</arm_group_label>
    <other_name>Glyceryl Trinitrate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is a male aged between 18 and 70 years inclusive, at screening&#xD;
&#xD;
          2. Confirmed clinical diagnosis of ED for more than 3 months according to the NIH&#xD;
             Consensus Statement ('the inability to achieve or maintain penile erection sufficient&#xD;
             for satisfactory sexual performance at least once')&#xD;
&#xD;
          3. Subject answers 'yes' to the question regarding the presence of residual EF over the&#xD;
             past 3 months: 'At home over the past 3 months, have you experienced at least some&#xD;
             growth of your penis in response to: (1) mechanical stimulation by yourself or your&#xD;
             partner, or (2) visual stimulation?'&#xD;
&#xD;
          4. Subject has been involved in a continuous heterosexual relationship for at least 6&#xD;
             months prior to screening&#xD;
&#xD;
          5. Documented written informed consent from both subject and his female partner&#xD;
&#xD;
          6. If the male subject's female partner is of childbearing potential from the time of&#xD;
             first sexual intercourse attempt during the screening period until the last&#xD;
             administration of study treatment, then the couple must have been using a medically&#xD;
             acceptable form of contraception for at least 3 months prior to entering the study,&#xD;
             and agree to continue such use for at least 1 month after the last study drug&#xD;
             administration. Subjects who are or wish to become pregnant will not be included in&#xD;
             the study.&#xD;
&#xD;
          7. Subject and his female partner are capable of understanding and complying with the&#xD;
             requirements of the protocol and must have signed the ICF prior to participation in&#xD;
             any study related procedures&#xD;
&#xD;
          8. Low IIEF-EF scores (≤ 25) during the screening period&#xD;
&#xD;
        To continue in the open-label extension phase of the study, subjects must meet the&#xD;
        following inclusion criteria at the follow-up visit of the double-blind phase (Visit 6):&#xD;
&#xD;
          1. Subject and his female partner complete the double-blind phase&#xD;
&#xD;
          2. Subject and his female partner were compliant to study procedures during the double&#xD;
             blind phase&#xD;
&#xD;
          3. Documented written informed consent from both subject and his female partner&#xD;
&#xD;
          4. If the male subject's female partner is of childbearing potential from the time of&#xD;
             first sexual intercourse attempt during the screening period until the last&#xD;
             administration of study treatment, then the couple must have been using a medically&#xD;
             acceptable form of contraception for at least 3 months prior to entering the study,&#xD;
             and agree to continue such use for at least 1 month after the last study drug&#xD;
             administration. Subjects who are or wish to become pregnant will not be included in&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any significant or serious cardiovascular, pulmonary, hepatic, renal,&#xD;
             gastrointestinal, haematological, endocrinological, metabolic, neurological or&#xD;
             psychiatric disease which, in the opinion of the PI, renders the subject unfit to take&#xD;
             part in the study&#xD;
&#xD;
          2. Subject has any history of an unstable medical or psychiatric condition or using any&#xD;
             medication that, in the opinion of the PI, is likely to affect the subject's ability&#xD;
             to complete the study or precludes the subject's participation in the study Certain&#xD;
             concomitant medications; e.g. other vasodilators, calcium channel blockers,&#xD;
             angiotensin converting enzyme (ACE) inhibitors, beta blockers, diuretics, anti&#xD;
             hypertensives, tricyclic anti depressants and major tranquillisers, as well as the&#xD;
             consumption of alcohol, may potentiate the BP lowering effects of MED2005; therefore,&#xD;
             the PI must consider this carefully and include subjects at their discretion&#xD;
&#xD;
          3. Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or&#xD;
             their delegate at screening or during the study&#xD;
&#xD;
          4. Any presence of chronic indwelling urethral catheterisation or penile anatomical&#xD;
             abnormalities (e.g. penile fibrosis) that would significantly impair EF&#xD;
&#xD;
          5. Any history of operations for Peyronie's disease&#xD;
&#xD;
          6. Primary hypoactive sexual desire or any history of hypogonadism&#xD;
&#xD;
          7. Any history of radical prostatectomy&#xD;
&#xD;
          8. Any history of severe/uncontrolled diabetes&#xD;
&#xD;
          9. Subjects taking two or more anti hypertensives for the treatment of BP&#xD;
&#xD;
         10. Hypersensitivity to GTN or to any of the excipients, or idiosyncratic reactions to&#xD;
             other organic nitrates&#xD;
&#xD;
         11. Concomitant treatment with sildenafil citrate, tadalafil, vardenafil and other PDE 5&#xD;
             inhibitors&#xD;
&#xD;
         12. Subjects taking Alpha blockers&#xD;
&#xD;
         13. Subjects receiving testosterone pellets&#xD;
&#xD;
         14. Any penile surgery except circumcision&#xD;
&#xD;
         15. Any treatment with acetyl cysteine within 6 months&#xD;
&#xD;
         16. Any treatment with dihydroergotamine within 6 months&#xD;
&#xD;
         17. Postural hypotension, hypotension or uncorrected hypovolaemia, as the use of GTN in&#xD;
             such states could produce severe hypotension or shock&#xD;
&#xD;
         18. Increased intracranial pressure (e.g. head trauma or cerebral haemorrhage) or&#xD;
             inadequate cerebral circulation&#xD;
&#xD;
         19. Any history of migraine or recurrent headache&#xD;
&#xD;
         20. Aortic or mitral stenosis&#xD;
&#xD;
         21. Hypertrophic obstructive cardiomyopathy&#xD;
&#xD;
         22. Constrictive pericarditis or pericardial tamponade&#xD;
&#xD;
         23. Closed-angle glaucoma&#xD;
&#xD;
         24. Subjects with nursing partners, known pregnant partners or with partners who wish to&#xD;
             become pregnant during the course of the study&#xD;
&#xD;
         25. Confirmed positive results from urine drug screen (amphetamines, benzodiazepines,&#xD;
             cocaine, cannabinoids, opiates, barbiturates, tricyclic antidepressants and methadone)&#xD;
             or from the alcohol breath test at screening (for clarification, any positive result&#xD;
             from the urine drug screen or alcohol breath tests at screening will mean the subject&#xD;
             will be excluded from the study). In the instance that a subject is using medication&#xD;
             which may give a positive result, exclusion will be at the PI's discretion&#xD;
&#xD;
         26. Subject has recent (last 12 months) clinical evidence of alcoholism or drug abuse.&#xD;
&#xD;
         27. Subject has a positive screen for hepatitis B, consisting of hepatitis B surface&#xD;
             antigen (HBsAG), hepatitis C antibody, and human immunodeficiency virus (HIV)&#xD;
&#xD;
         28. Any clinically significant abnormal laboratory, vital signs or other safety findings&#xD;
             as determined by medical history, physical examination or other evaluations conducted&#xD;
             at screening or on admission&#xD;
&#xD;
         29. Subjects unwilling to cease use of vacuum devices, intracavernosal injections, PDE-5s&#xD;
             or other therapy for ED for the entire course of the study&#xD;
&#xD;
         30. Unwillingness of the subject or their partner to agree to make the required attempts&#xD;
             at sexual intercourse during treatment period&#xD;
&#xD;
         31. Any history of unresponsiveness to PDE 5 treatment or significant side effects,&#xD;
             excluding visual disturbances, with PDE 5s&#xD;
&#xD;
         32. Fewer than four attempts at sexual intercourse during the screening period&#xD;
&#xD;
         33. Subjects or their partners who are illiterate or are unable to understand the language&#xD;
             in which the questionnaires are available&#xD;
&#xD;
         34. Subject has received any investigational product during the 90 days prior to dosing&#xD;
             for this study&#xD;
&#xD;
         35. Subject or his partner cannot communicate reliably with the PI&#xD;
&#xD;
         36. Subjects with severe premature ejaculation (little or no control of ejaculation at the&#xD;
             time of penetration)&#xD;
&#xD;
        Subjects are prohibited from participating in the open-label extension phase of the study&#xD;
        if they meet any of the following exclusion criteria at the follow-up visit of the&#xD;
        double-blind phase (Visit 6):&#xD;
&#xD;
          1. Subsequent to recruitment into the double-blind phase of the study, the development of&#xD;
             any significant or serious cardiovascular, pulmonary, hepatic, renal,&#xD;
             gastrointestinal, haematological, endocrinological, metabolic, neurological or&#xD;
             psychiatric disease which, in the opinion of the PI, renders the subject unfit to&#xD;
             continue in the open-label extension phase of the study&#xD;
&#xD;
          2. Subject using any medication that, in the opinion of the PI, is likely to affect the&#xD;
             subject's ability to complete or participate in the open-label phase of the study.&#xD;
&#xD;
             NB The concomitant medications listed as exclusion criteria for the study apply to the&#xD;
             open-label extension phase. Certain concomitant medications; e.g. other vasodilators,&#xD;
             calcium channel blockers, ACE inhibitors, beta blockers, diuretics, anti&#xD;
             hypertensives, tricyclic anti depressants and major tranquillisers, as well as the&#xD;
             consumption of alcohol, may potentiate the BP lowering effects of MED2005; therefore,&#xD;
             the PI must consider this carefully and include subjects at their discretion&#xD;
&#xD;
          3. Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or&#xD;
             their delegate at the start of the open-label extension phase&#xD;
&#xD;
          4. Subsequent to recruitment into the double-blind phase of the study, the development of&#xD;
             postural hypotension, hypotension or uncorrected hypovolaemia, increased intracranial&#xD;
             pressure or inadequate cerebral circulation, any clinically significant vital signs or&#xD;
             other safety findings as determined by medical history, physical examination or other&#xD;
             evaluations conducted at Visit 6 prior to recruitment to the open-label phase&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Male patients must have been in a heterosexual relationship with a female partner for a minimum of 6 months</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tim J Holland, MBA</last_name>
    <role>Study Director</role>
    <affiliation>Clinical Development Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UMHAT Burgas EAD</name>
      <address>
        <city>Burgas</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment</name>
      <address>
        <city>Pleven</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment</name>
      <address>
        <city>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Office Diagnostic-Consultative Center</name>
      <address>
        <city>Varna</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Biomed</name>
      <address>
        <city>Vidin</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>URAN MUDr.Jan Hiblbauer s.r.o</name>
      <address>
        <city>Hradec Králové</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ANDROGEOS, spol. s.r.o.</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urosante s.r.o.</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD Gormedi</name>
      <address>
        <city>Gori</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD Gidmedi</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD Multiprofile Clinic Consilium Medulla</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTDHealth House</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Magyarorszag Kft</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Civis Egeszseghaz</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korona Prevent-Med Kft.</name>
      <address>
        <city>Sopron</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aranyklinika</name>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Latgales Urology Center</name>
      <address>
        <city>Daugavpils</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>V. Lietuviesa Private Practice</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vidzemes Hospital</name>
      <address>
        <city>Valmiera</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indywidualna Specjalistyczna Praktyka Lekarska Dr Adam Sipinski</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROVITA Specjalistyczna Praktyka Ginekologiczno-Seksuologiczna</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indywidualna Specjalistyczna Praktyka Lekarska</name>
      <address>
        <city>Szczecin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabinet Lekarski Ryszard Smolinski</name>
      <address>
        <city>Wrocław</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Budgetary Healthcare Institution &quot;Ivanovskaya Regional Clinical Hospital&quot;</name>
      <address>
        <city>Ivanovo</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CJSC &quot;Nasledniki&quot;</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Institution &quot;National Medical Research Center of Obstetrics, Gynecology and Perinatology n.a. acad. V.I. Kulakov&quot; of the Ministry of Healthcare of the Russian Federation</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBEI HE &quot;Russian National Research Medical University n.a. N.I. Pirogov&quot; of the Ministry of Healthcare of the Russian Federation, Russian Gerontological Scientific and Research Center</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC &quot;Bessalar Clinic&quot;</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC &quot;Unimed-S&quot;</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Institution &quot;Hospital for War Veterans&quot;</name>
      <address>
        <city>Rostov-on-Don</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Educational Institution of Higher Education &quot;North-Western State Medical University n.a. I.I. Mechnikov&quot; of the Ministry of Healthcare of the Russian Federation</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC &quot;Medical center PRIME ROSE&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC &quot;Sanavita&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Llc &lt;&lt;Mart&gt;&gt;</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicosanitary Department No.70, branch of Saint-Petersburg State Unitary Institution of road passenger transport</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center &quot;Eco-Safety&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Petersburg State Budgetary Healthcare Institution &quot;City Polyclinic No. 4&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital n.a. S.R. Mirotvortseva of the Federal State Budgetary Educational Institution of Higher Education &quot;Saratovskiy State Medical University n.a. V.I. Razumovskiy&quot; of the Ministry of Healthcare of the Russian Federation</name>
      <address>
        <city>Saratov</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Educational Institution of Higher Education &quot; Voronezhskiy State Medical University n.a. N.N. Burdenko&quot; of the Ministry of Healthcare of the Russian Federation on the clinical base of Budgetary Healthcare Institution of Voronezhsk</name>
      <address>
        <city>Voronezh</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBHI of Leningradskaya region &quot;Vsevolozhskaya Clinical Interdistrict Hospital&quot;</name>
      <address>
        <city>Vsevolozhsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBEI HPE &quot;Yaroslavskiy State Medical University&quot; of The Ministry of Healthcare of the Russian Federation with clinical base in State Autonomous Institution of Yaroslavskaya region &quot;Clinical Hospital No.9&quot;</name>
      <address>
        <city>Yaroslavl</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urologicka ambulancia</name>
      <address>
        <city>Košice</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urologicka ambulancia Urobet s.r.o.</name>
      <address>
        <city>Malacky</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urologicka ambulancia Uroexam s.r.o.</name>
      <address>
        <city>Nitra</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Privatna urologicka ambulancia s.r.o.</name>
      <address>
        <city>Trenčín</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Establishment &quot;Cherkasy Regional Hospital of Cherkasy Regional Council&quot;, Urology department</name>
      <address>
        <city>Cherkasy</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital, Polyclinic Department</name>
      <address>
        <city>Ivano-Frankivs'k</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv Clinical Hospital on Railway Transport #1 of the branch &quot;Health Center&quot; of the public joint stock company &quot;Ukrainian Railway&quot;, consulting and diagnostic center</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Institution &quot;Institute of urology of the National Academy of Medical Science of Ukraine&quot;, policlinic department</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Institution &quot;Institute of urology of the National Academy of Medical Sciences of Ukraine&quot;, Department of Sexual Pathology and Andrology</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Ambulatory of General Practice-Family Medicine&quot;,LLC, Medical Center</name>
      <address>
        <city>Odesa</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Small-Scale Enterprise Medical Centre &quot;Pulse&quot; , Therapeutic Department</name>
      <address>
        <city>Vinnytsia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution Central City Hospital №1 of Zhytomyr, consulting and medical department &quot;Research center&quot;</name>
      <address>
        <city>Zhytomyr</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Czechia</country>
    <country>Georgia</country>
    <country>Hungary</country>
    <country>Latvia</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Ukraine</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>February 28, 2022</last_update_submitted>
  <last_update_submitted_qc>February 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Nitroglycerin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03813992/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>August 24, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03813992
org study id: FM57
nct id: NCT03813992
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To demonstrate the efficacy of various doses of MED2005 versus placebo in male patients with
      clinically diagnosed erectile dysfunction, and to evaluate the long-term efficacy and safety
      (12 months) of MED2005.
A phase III, dose-ranging, multi-centre, randomised, double-blind, placebo controlled ,
      home-use, parallel group clinical trial of topically applied glyceryl trinitrate for the
      treatment of erectile dysfunction with an open label extension
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: International Index for Erectile Function (IIEF) Questionnaire
time frame: Up to Week 64 of the study
description: A questionnaire containing 15 questions divided into 5 domains; erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.
measure: Sexual Encounter Profile (SEP) Questionnaire (Question 2)
time frame: Up to Week 64 of the study
description: A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.
measure: Sexual Encounter Profile (SEP) Questionnaire (Question 3)
time frame: Up to Week 64 of the study
description: A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.
measure: Self-Esteem and Relationship (SEAR) Questionnaire
time frame: Up to Week 12 of the study.
description: A questionnaire to support the validity and reliability for measuring sexual relationship satisfaction, satisfaction, confidence, and self-esteem in men with erectile dysfunction.
measure: Global Assessment Questionnaire (GAQ)
time frame: Up to Week 12 of the study.
description: A questionnaire that allows patients and their partners to rate (yes or no) an improvement in erectile function.
measure: International Index for Erectile Function (IIEF) Questionnaire (additional domains)
time frame: Up to Week 64 weeks of the study.
description: A questionnaire containing 15 questions divided into 5 domains; erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.
measure: Sexual Encounter Profile (SEP) Questionnaire (Questions 1, 4 & 5)
time frame: Up to Week 64 of the study.
description: A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.
measure: Sexual Encounter Profile (SEP) Questionnaire
time frame: Up to Week 64 of the study
description: A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.
measure: Patient Global Impression of Severity (PGI-S)
time frame: Up to Week 12 of the study.
description: A one item questionnaire to rate the severity of a patient's erectile dysfunction. This is a single-state 5-point categorical scale.
measure: Patient Global Impression of Change (PGI-C)
time frame: Up to Week 12 of the study
description: A one item questionnaire to rate a perceived change in a patient's erectile function. This is a transitional 7-point categorical scale.
measure: Onset and duration of action (erection) and erection hardness
time frame: Up to Week 12 of the study
description: A questionnaire asking both the patient and the patient's partner about the onset and duration of action of the patient's erection.
measure: Usage and application
time frame: Up to Week 12 of the study
description: A questionnaire has 5 items to assess the usage and application of the investigation product.
arm group label: MED2005 0.2%
arm group type: Active Comparator
description: MED2005 0.2% w/w gel to deliver 0.6 mg dose of GTN applied topically prior to a sexual intercourse attempt
arm group label: MED2005 0.4%
arm group type: Active Comparator
description: MED2005 0.4% w/w gel to deliver 1.2 mg dose of GTN applied topically prior to a sexual intercourse attempt
arm group label: MED2005 0.6%
arm group type: Active Comparator
description: MED2005 0.6% w/w gel to deliver 1.8 mg dose of GTN applied topically prior to a sexual intercourse attempt
arm group label: Placebo vehicle
arm group type: Placebo Comparator
description: Placebo vehicle applied topically prior to a sexual intercourse attempt
intervention type: Drug
intervention name: MED2005
description: Topical Product
arm group label: MED2005 0.2%
arm group label: MED2005 0.4%
arm group label: MED2005 0.6%
arm group label: Placebo vehicle
other name: Glyceryl Trinitrate
criteria: 
gender: Male
gender based: Yes
gender description: Male patients must have been in a heterosexual relationship with a female partner for a minimum of 6 months
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Tim J Holland, MBA
role: Study Director
affiliation: Clinical Development Director
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country: Bulgaria
country: Czechia
country: Georgia
country: Hungary
country: Latvia
country: Poland
country: Russian Federation
country: Slovakia
country: Ukraine
responsible party type: Sponsor
mesh term: Erectile Dysfunction
mesh term: Nitroglycerin
sharing ipd: No
provided document: 
submitted: August 24, 2023