- To demonstrate the efficacy of MED2005 versus placebo in male subjects clinically diagnosed with ED using the EF domain of the IIEF, the Sexual Encounter Profile (SEP) Question 2 and the SEP Question 3. The primary objective will be addressed by estimating the following estimand: difference between treatment policies (each MED2005 dose versus placebo) in all subjects who met the study inclusion/exclusion criteria and who were randomised and attempted intercourse post-randomisation at least once, assessed via the change compared to baseline in EF [IIEF EF], the ability to achieve vaginal penetration [SEP Question 2] and the ability to have successful intercourse [SEP Question 3] over 12 weeks of treatment