Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED)
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the efficacy and safety of MED2005, a topically applied
      glyceryl trinitrate (GTN) gel administered to the penis of male subjects self-diagnosed with
      erectile dysfunction (ED) immediately before sexual intercourse.
    

Detailed description: 
      This randomised, double-blind, placebo-controlled cross-over study is designed to evaluate
      the efficacy and safety of MED2005, a topically applied glyceryl trinitrate (GTN) gel
      administered to the penis of male subjects immediately before sexual intercourse. Subjects
      will be male aged between 18 and 70 years of age self-diagnosed with ED. Treatment requires
      the topical application of a pea sized volume (approximately 300 mg) of a 0.2% (w/w) gel to
      deliver a dose of 0.6 mg GTN to the glans of the penis. A total of 192 eligible subjects are
      planned to be enrolled into the study. Subjects will be screened for eligibility during the
      screening period (Day -45 to Day -2), provide a history of their ED treatments and those
      deemed eligible and who have a female consenting partner will participate in a run-in-period
      and two treatment periods (treatment period 1 and 2). The International Index for Erectile
      Function (IIEF) question 1 -5 and 15 will be used to determine pre-screening eligibility for
      the subject online. A score of 25 or less will be acceptable for inclusion to the
      run-in-period. Screening (visit 1) will be conducted over 1 day or may be divided into more
      than 1 day if wash-out of prior medications is needed. The screening period is applicable for
      visit 1 Informed consent will be signed by both partners before a couple can be admitted to
      the study. There will also be a subject and partner training requirement to ensure that the
      product is applied in an appropriate manner. After refraining from using other ED treatments
      for at least a period of a week, in the run-in-period (visit 2), subjects and their female
      partners will make at least 4 intercourse attempts (with a minimum of 1 attempt per week)
      during a 4 week (± 1 week) period. The subjects and their partners will be asked to complete
      questionnaires online to record their experiences after each sexual intercourse attempt and
      at the end of the run-in period. Subjects who cannot comply with the minimum number of sexual
      attempts verified by completed Sexual Event Profile (SEP) or exceed 25 on the IIEF question 1
      -5 and 15 will be excluded from the study. Scores generated from the run-in period will be
      used as an established baseline in the planned analyses. The run-in period will be completed
      prior to randomisation and dosing.

      In treatment period 1 (visit 3 and visit 4), subjects will be allocated to receive either
      placebo or MED2005 (0.6 mg GTN) according to a pre-defined randomisation schedule. After
      refraining from using other ED treatments for at least a period of a week, subjects and their
      female partner will be trained in the application of the test article and asked to apply the
      test article immediately prior to sexual intercourse, and to make at least 4 intercourse
      attempts during a 4 week (± 1 week) period. The subjects and their partners will be asked to
      complete questionnaires online to record their experiences after each sexual intercourse
      attempt, and again at the end of each treatment period. Subjects will be asked to return to
      the Clinical Pharmacology Unit (CPU) after 4 weeks' (± 1 week) to return used and unused test
      article from the first treatment period, to enable the clinical staff to check compliance and
      to assess their health status, including assessment of any Adverse Event (AE). At the end of
      treatment period 1 (visit 4), tubes will be weighed to ensure subject compliance.

      Following a 1 week treatment-free cross-over period, the subjects will enter into treatment
      period 2.

      In treatment period 2 (visit 5 and visit 6), subjects will be issued with the alternative
      test article, either placebo or MED2005 (0.6 mg GTN) according to the pre-defined
      randomisation code. Training on the application of the test article will be reinforced /
      repeated and the subject or their female partner will be asked to apply the test article
      immediately prior to sexual intercourse on at least 4 separate occasions during a 4-week
      period. After each intercourse attempt the subjects and their partners will be asked to
      complete questionnaires online to record their experiences after each sexual intercourse
      attempt, and again at the end of each treatment period.. Subjects will be asked to return to
      the CPU after 4 weeks' (± 1 week) time to return used and unused test article from the second
      treatment period, to enable the clinical staff to check compliance and to assess their health
      status, including assessment of any AEs. At the end of treatment period 2 (visit 6), tubes
      will be weighed to ensure subject compliance.

      Subjects and their female partners will be followed up at 7 day's ± 2 days (visit 7) after
      the outpatient visit on week 4 of treatment period 2, as necessary, to follow up any on-going
      AEs.
    

Intervention name(s): Glyceryl trinitrate; MED Placebo
Intervention type(s): Drug; Drug
Intervention description(s): At least 4 applications of MED2005 prior to intercourse over a period of 4 weeks; At least 4 applications of MED2005 prior to intercourse over a period of 4 weeks
Other intervention name(s): MED2005; MED2005 Vehicle
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment