Efficacy and safety of simenafil in erectile dysfunction: a phase II, randomized, double-blind, placebo-controlled, crossover study.
Zhe Zhang, Tao Jiang, Yu-Tian Dai et al.
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In 30 seconds
This phase II, randomized, double-blind, placebo-controlled, multicenter crossover study assessed single-dose simenafil using RigiScan during audiovisual sexual stimulation in 84 men aged 18–65 years with mild-to-moderate erectile dysfunction. Compared with placebo, simenafil 2.5 mg increased the duration of at least 60% penile rigidity at the base by 8.3 min (95% CI: 3.5–13.2 min, P = 0.001); 5.0 mg increased it by 8.5 min (95% CI: 3.5–13.5 min, P = 0.001). The 10.0 mg dose also prolonged base rigidity, while several other dose-site comparisons were not statistically significant. The authors considered the findings supportive of further investigation.
Key findings
- In Cohort A, 2.5 mg simenafil increased base rigidity duration versus placebo by 8.3 min (95% CI: 3.5–13.2 min, P = 0.001).
- In Cohort A, 5.0 mg increased base rigidity duration versus placebo by 8.5 min (95% CI: 3.5–13.5 min, P = 0.001).
- In Cohort B, 10.0 mg increased base rigidity duration versus placebo by 5.9 min (95% CI: 0.8–10.9 min, P = 0.023); tip rigidity duration was not significantly different.
Why it matters
The study provides objective RigiScan evidence that simenafil can prolong penile rigidity in men with mild-to-moderate erectile dysfunction, while also assessing safety. The dose- and measurement-site-specific results show why efficacy should not be assumed across all doses or outcomes. These phase II findings add early clinical evidence for a candidate PDE5 inhibitor but do not establish its role relative to existing treatments.
What to keep in mind
The study assessed single doses and an objective rigidity endpoint during audiovisual stimulation; the abstract does not report longer-term outcomes or effectiveness in usual sexual activity.