A closely-followed prototype drug for tackling premature ejaculation was found to be safe and effective among Americans, says Lancet.
PARIS: A closely-followed prototype drug for tackling premature ejaculation was found to be safe and effective in a large-scale trial among American men, investigators report in The Lancet.
The drug, which is goes under the lab name of dapoxetine hydrochloride, will be the first pharmaceutical treatment specifically intended for premature ejaculation if the US Food and Drug Administration (FDA) and other licensors give their approval.
Researchers looked at two trials that involved 2,600 men with an average age of just over 40, and who had moderate to severe premature ejaculation.
Their partners were also enrolled in the project. The volunteers were instructed to attempt sexual intercourse four times or more during a two-week "baseline" period — a period designed to be a comparison to see how the drug, to be taken later, would perform.
The men ejaculated within 54 seconds of vaginal penetration, the baseline figures showed. A third of the patients then received a placebo. The remaining two-thirds were given either a 30-mg dose of dapoxetine or a 60mg dose. Over the next 12 weeks, the couples were asked to attempt intercourse six times or more per month. The tablets were to be taken between one and three hours before intercourse, and the time to ejaculation and any side effects were to be noted in a logbook. Men who took the placebo extended their time to ejaculation to 1.75 minutes; for those on the 30mg dose, it was 2.78 minutes, and for those on 60mg, it was 3.32 minutes.
A fifth of those on the 60mg dose experienced nausea, among the 30mg group. Diarrhoea, headache and dizziness were also reported. Despite this, the assessors describe dapoxetine as "an effective and generally well-tolerated treatment" that improved time to ejaculation "significantly". The study said that premature ejaculation is a problem that affects between 21 and 33 per cent of men, and is more prevalent than impotence. Also, Dapoxetine is in a class of antidepressant drugs called selective serotonin reuptake inhibitors (SSRIs).
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