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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.
Full description
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
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Inclusion criteria
To continue in the open-label extension phase of the study, subjects must meet the following inclusion criteria at the follow-up visit of the double-blind phase (Visit 6):
Exclusion criteria
Subjects are prohibited from participating in the open-label extension phase of the study if they meet any of the following exclusion criteria at the follow-up visit of the double-blind phase (Visit 6):
Subsequent to recruitment into the double-blind phase of the study, the development of any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease which, in the opinion of the PI, renders the subject unfit to continue in the open-label extension phase of the study
Subject using any medication that, in the opinion of the PI, is likely to affect the subject's ability to complete or participate in the open-label phase of the study.
NB The concomitant medications listed as exclusion criteria for the study apply to the open-label extension phase. Certain concomitant medications; e.g. other vasodilators, calcium channel blockers, ACE inhibitors, beta blockers, diuretics, anti hypertensives, tricyclic anti depressants and major tranquillisers, as well as the consumption of alcohol, may potentiate the BP lowering effects of MED2005; therefore, the PI must consider this carefully and include subjects at their discretion
Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or their delegate at the start of the open-label extension phase
Subsequent to recruitment into the double-blind phase of the study, the development of postural hypotension, hypotension or uncorrected hypovolaemia, increased intracranial pressure or inadequate cerebral circulation, any clinically significant vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at Visit 6 prior to recruitment to the open-label phase
Primary purpose
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Interventional model
Masking
1,005 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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