(006) efficacy and safety of on-demand therapy with clomipramine/sildenafil combination compared to on-demand therapy with clomipramine or sildenafil alone in patients with premature ejaculation: a prospective, randomized, double-blinded, active-controlled, 3-T
Abstract
Premature ejaculation (PE) is one of the most common male sexual dysfunctions with various treatment options. Clomipramine is commonly used for PE in clinical practice, and is considered first-line pharmacotherapy in recent AUA guidelines. Sildenafil is the best-known drug for erectile dysfunction (ED), and has also shown a positive effect for PE in several clinical trials. Meanwhile, many studies have demonstrated that several selective serotonin reuptake inhibitors (SSRIs) combined with sildenafil is superior to SSRI or sildenafil monotherapy for PE. However, to our knowledge, there are no studies on the utility of clomipramine combined with sildenafil.
We assessed the efficacy and safety of on-demand therapy with clomipramine 15 mg/sildenafil 50 mg combination compared with clomipramine or sildenafil alone in men with PE without ED.
Our prospective, randomized, double-blinded, active-controlled, 3-treatment arm, multi-center trial enrolled 795 men with PE without ED. Subjects were recruited between October 2019 and April 2022 at 24 institutions in Korea. PE was defined as (1) history on DSM-V, (2) PEDT ≥11 score, and (3) IELT <3 minute. Subjects were divided into three groups: clomipramine 15 mg (group A, n = 265), sildenafil 50 mg (group B, n = 266) and clomipramine 15 mg/sildenafil 50 mg (group C, n = 264). During 12 weeks, stopwatch-measured IELT and patients reported outcomes (PEP, PGIC) were measured. Any treatment-emergent adverse events (TEAEs) were also recorded.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 795 participants or records.
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