Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED)
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Glyceryl trinitrate; MED Placebo
Intervention description: 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
Intervention MeSH terms: Nitroglycerin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 232.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male aged between 18 and 70 years of age inclusive.

          2. Confirmed self-diagnosis of ED for more than 3 months.

          3. IIEF question 1 -5 and 15 score of 25 or less will be acceptable for inclusion to the
             run-in period.

          4. Subject answers "yes" to the question "At home over the past 3 months, have you
             experienced at least some growth of your penis in response to: (1) mechanical
             stimulation, or (2) visual stimulation?"

          5. In a continuous heterosexual relationship for at least 6 months prior to screening.

          6. Documented written informed consent from both subject and his female partner.

          7. Both partners must agree to use one of the acceptable methods of contraception listed
             below:

               -  Occlusive cap (diaphragm or cervical/vault caps).

               -  Surgical sterilisation (vasectomy with documentation of azoospermia).

               -  The female partner uses oral contraceptives, injectable progesterone or subdermal
                  implants.

               -  The female partner uses medically prescribed topically-applied transdermal
                  contraceptive patch.

               -  The female partner has undergone documented tubal ligation (female
                  sterilisation).

               -  The female partner has undergone documented placement of an Intra Uterine Device
                  (IUD).

          8. Both partners are capable of understanding and complying with the requirements of the
             protocol and must have signed the informed consent form.

        Exclusion Criteria:

          1. Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal,
             haematological, endocrinological, metabolic, neurological, psychiatric, or other
             disease.

          2. Any history of an unstable medical or psychiatric condition or using any medication
             that, in the opinion of the PI, is likely to affect the subject's ability to complete
             the study or precludes the subject's participation in the study.

          3. Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or
             delegate at screening.

          4. Any presence of chronic indwelling urethral catheterization or penile anatomical
             abnormalities (e.g. penile fibrosis) that would significantly impair erectile
             function.

          5. Any history of operations for Peyronie's disease.

          6. Primary hypoactive sexual desire or any history of hypogonadism

          7. Any history of radical prostatectomy.

          8. Any history of severe / uncontrolled diabetes.

          9. Subjects taking two or more anti-hypertensives for the treatment of blood pressure.

         10. Subjects with nursing partners, known pregnant partners or wish to become pregnant
             during the course of the study.

         11. Confirmed positive results from urine drug screen or from the alcohol breath test at
             screening and on admission (Day -1).

         12. Subject has recent (last 12 months) clinical evidence of alcoholism or drug abuse.

         13. Subject has a positive screen for hepatitis B consisting of Hepatitis B surface
             antigen (HBsAG), hepatitis C antibody, and human immunodeficiency virus (HIV).

         14. Any clinically significant abnormal laboratory, vital signs or other safety findings
             at screening or on admission.

         15. Subjects unwilling to cease use of vacuum devices, intracavernosal injection, Viagra ®
             or other therapy for ED.

         16. Unwillingness of the subject to agree to make four attempts at sexual intercourse on
             four separate days during each treatment period.

         17. Any history of unresponsiveness to Viagra ® treatment due to lack of efficacy with
             sexual stimulation after multiple attempts of sexual intercourse, or significant side
             effects excluding visual disturbances of Viagra ®.

         18. Less than 4 attempts at sexual intercourse or high IIEF scores (> 25) during the
             run-in period.

         19. Any known hypersensitivity to any component of the investigational product.

         20. Subjects who are illiterate or are unable to understand the language in which the
             online questionnaires are available.

         21. Subject has received any investigational product during the 90 days prior to dosing
             for this study.

         22. Subject or their partner cannot communicate reliably with the Investigator.