The journal of sexual medicine
Treatment with sildenafil oral film improves orgasmic intensity: a secondary, exploratory post-hoc analysis of a randomized placebo-controlled trial
By Sansone A, Colonnello E, Efros MD and 8 others.
Abstract
Background
Erectile dysfunction (ED) impairs sexual function beyond erection itself, yet its effect on orgasmic intensity, measurable by the validated psychometric tool Orgasmometer, remains largely unexplored. Sildenafil oral film (OF) is a novel formulation offering rapid dissolution and flexible dosing (25-100 mg, including an intermediate 75 mg dose).
Aim
To investigate the relationship between ED severity and orgasmic intensity, and to evaluate whether Sildenafil OF restores orgasmic intensity in men with ED.
Methods
This secondary, exploratory analysis of orgasmic intensity was not prespecified and was performed post-hoc on a Phase III, multicenter, randomized, double-blind, flexible-dose, placebo-controlled trial conducted across 17 US centers (January-December 2024; NCT05490680). Heterosexual men with a ≥6-month ED diagnosis were randomized 3:1 to Sildenafil OF or placebo for 12 weeks. Outcomes were assessed at baseline and at weeks 2, 4, 8, and 12.