Efficacy and Safety of On-Demand Clomipramine for the Treatment of Premature Ejaculation
The Journal of Urology:
Clomipramine is a tricyclic
antidepressant (TCA) that has been found effective at a daily dose of 25 mg or
50 mg for premature ejaculation (PE) in multiple studies.
Additionally, TCAs can carry
significant side effects such as dizziness, dry mouth, and constipation.
As a result, on-demand treatment is
greatly preferred, especially when cost is taken into account.
This phase III double-blind
randomized controlled trial provides much-needed evidence establishing the
effectiveness of on-demand clomipramine for PE.
TAKE-HOME MESSAGE
The aim of
the present trial is to assess the efficacy of on-demand clomipramine 15 mg
administered before sexual intercourse for the treatment of premature
ejaculation (PE).
This study
randomized men with premature ejaculation (PE) to either low-dose (15
mg) clomipramine, a tricyclic antidepressant, or placebo and measured
efficacy using Intravaginal Ejaculation Latency Time (IELT) and the Premature
Ejaculation Diagnostic Tool (PEDT).
Investigators
found treatment with clomipramine resulted in marked improvements in both
IELT and PEDT. Low-dose clomipramine was well-tolerated, with no
observed serious adverse events.
Although
on-demand dosing is theoretically less toxic than daily dosing, nearly half of
the men in the treatment group (49/102, or 48%) had a side effect. The authors
did mention that most of the side effects were mild and resolved without
medical intervention
This study
demonstrated that on-demand oral clomipramine is a highly desirable treatment
for PE. On-demand oral clomipramine significantly increased the IELT and only
needed to be taken several times a month, at times when intercourse was
desired.
These data
suggest that on-demand low-dose clomipramine is a safe
and effective treatment for PE.
Doctors Liked to Read More
Purpose: The aim of
the current trial was to assess the efficacy of on demand clomipramine 15 mg
administered before sexual intercourse for the treatment of premature
ejaculation.
Materials and methods: A total of
159 patients at 5 centers in Korea were randomly assigned to 2 groups. The
first group of 53 men received placebo and the second group of 106 received
clomipramine 15 mg for 12 weeks. All patients were evaluated at the beginning
of the study and every 4 weeks thereafter. Patients were instructed to ingest a
tablet approximately 2 to 6 hours before sexual intercourse. Efficacy was
assessed by scores on the IELT (Intravaginal Ejaculation Latency Time) and the
PEDT (Premature Ejaculation Diagnostic Tool).
Results: Analyses of
the IELT fold change in each group in the intent to treat population revealed
that the IELT of the clomipramine 15 mg group was significantly increased 12
weeks after administration compared with the placebo group. The IELT fold
change in the per protocol population also significantly differed between the
clomipramine 15 mg group and the placebo group. There was a significant
difference in the PEDT scores between the 2 groups (p <0.001). The most
commonly reported adverse events were nausea in 15.7% of men and dizziness in
4.9%. Adverse events were mild to moderate in severity.
Conclusions: The results
of this multicenter, randomized, double-blind, placebo controlled, fixed dose
clinical phase III study suggest that administering clomipramine 15 mg on
demand to treat premature ejaculation is effective and safe.
Comments
You must login to write comment