On-demand use of clomipramine effective, safe in men with premature ejaculation
Use of clomipramine as an on-demand treatment of premature ejaculation is well tolerated and effective, with the results of a phase III study showing increased ejaculation time during vaginal penetration.
A total of 159 patients with premature ejaculation were randomized to receive clomipramine 15 mg (n=106) or placebo (n=53) orally for 12 weeks. Patients were instructed to take the drug around 2–6 hours prior to planned sexual intercourse. They underwent evaluations at baseline and every 4 weeks.
Treatment efficacy was evaluated using Intravaginal Ejaculation Latency Time (IELT) and Premature Ejaculation Diagnostic Tool (PEDT) scores.
After 12 weeks of treatment, the mean IELT significantly increased in the clomipramine 15 mg group than in the placebo group (intention-to-treat: 4.40±5.29 vs 2.68±2.03; p<0.05). Fold change of IELT in the per-protocol population was also significantly different between the two treatment groups, in favour of the active drug (mean: 4.66±5.64 vs 2.80±2.19; p<0.05).
Likewise, there was a significant between-group difference in PEDT scores, which were better with clomipramine vs placebo (p<0.001).
Adverse events were mild to moderate in severity. The most commonly reported were nausea (15.7 percent) and dizziness (4.9 percent).
A tricyclic antidepressant, clomipramine hydrochloride is indicated for obsessive-compulsive disorder, panic disorder and depressive disorder. The drug is said to be the most potent inhibitor of 5- hydroxytryptamine (serotonin) reuptake among antidepressants. Side effects include dry mouth, nausea, constipation, loss of appetite, fatigue and dizziness. [Int J Impot Res 2018;30:65-70]