Efficacy and Tolerability of On-Demand Oral Pregablin in Treatment of Premature Ejaculation
The Journal of Sexual Medicine: January 2020
Premature ejaculation (PE) is a
common sexual dysfunction; the available options for PE treatment remain
unsatisfactory.
Premature ejaculation (PE) is the
most common form of male sexual dysfunction. Globally, between 20% and 40% of
men, at some point in their lives, have reported complaint of PE.
The International Society of Sexual
Medicine (ISSM) produced its guidelines of the diagnosis and management of PE.
It postulated an evidence-based definition of PE and defined PE as ―A male
sexual dysfunction characterized by ejaculation which is always or nearly
always occurs prior to or within 1 minute of vaginal penetration; and an
inability to delay ejaculation on all or nearly all vaginal penetrations, and
negative personal consequences, such as distress, bother, frustration, and/or
the avoidance of sexual encounters.
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The authors
of this study evaluated the effect of pregabalin on premature ejaculation. They
performed a double-blinded placebo-controlled randomized clinical trial in
which patients received 150 mg or 75 mg of pregabalin or placebo.
All
patients engaged in sexual intercourse two times per week and took the
medication prior to intercourse.
Intravaginal
ejaculation latency time improved 2.45 +/− 1.43-fold (145%) in patients
receiving 150 mg pregabalin. The Intravaginal Ejaculation Latency Time (IELT) is
the time from vaginal intromission to intravaginal ejaculation.
Most PE
patients showed a significant improvement after receiving on-demand pregabalin
(150 mg).
Conclusion
Oral
pregabalin may represent an option for improving premature ejaculation. On
demand oral pregabalin 150 mg 1 – 2 hours prior to sexual relation, looks to be
effective pharmacotherapy of premature ejaculation. The effect of pregabalin is
minimal and may be augmented with higher daily doses.
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Aim: To evaluate
the effect of on-demand oral pregabalin on the intravaginal ejaculation latency
time (IELT).
Method: We conducted
a multiarm double-blinded placebo-controlled randomized clinical trial that
enrolled 120 patients with PE who were divided equally into 3 groups (A, B, and
C). 4 patients were excluded, 39 patients received 150 mg pregabalin (group A),
39 patients received 75 mg pregabalin (group B), and 38 patients received
placebo (group C). All patients were encouraged to engage in sexual relations
twice per week for 2 weeks and to take the medication 1-2 hours before sexual
intercourse. A stopwatch was used to evaluate IELT.
Main outcome measure: The main
outcome measure are the improvement of IELT and the reported adverse events.
Results: IELT
significantly improved in patients who received 150 mg pregabalin, but there
was no change in the other groups.
Clinical implications: Most PE
patients showed a significant improvement after receiving on-demand pregabalin
(150 mg).
Strength & limitations: The
strength of this study is that it is the first randomized controlled trial to
evaluate the efficacy of pregabalin in treatment of PE. The main limitations
were the small number of patients, IELT was the only primary outcome of the
study, and the pregabalin cap can be identified by the patient.
Conclusion: Oral
pregabalin seems to be a promising drug for additional evaluation as a new
treatment for PE. More studies are needed to evaluate the suitable dose,
duration, timing, and its safety profile. El Najjar MR, El Hariri M, Ramadan A,
et al. A Double Blind, Placebo Controlled, Randomized Trial to Evaluate the
Efficacy and Tolerability of On-Demand Oral Pregablin (150 mg and 75 mg) in
Treatment of Premature Ejaculation. J Sex Med 2020;17:442-446.
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