This study was designed to examine the efficacy and safety of sertrali
ne as a treatment for premature ejaculation. Fifty-two heterosexual ma
le patients with self-reported premature ejaculation were randomly ass
igned to receive either sertraline or placebo. After a 1-week placebo
washout period, the dose was titrated during treatment weeks 1 to 3 fr
om 50 to 200 mg of sertraline per day until clinical response was opti
mal or dose-limiting adverse experiences emerged. Medication was maint
ained at this level through week 8. The primary outcome measures used
to assess efficacy included patient assessment of time to ejaculation
(from penetration), number of successful attempts at intercourse, and
incidence of ejaculation during foreplay. Sertraline treatment produce
d significant improvements relative to placebo in time to ejaculation
and number of successful attempts at intercourse, as well as overall c
linical judgements of improvement. Medication was well tolerated by mo
st patients. Because sertraline therapy caused significant prolongatio
n of time to ejaculation, this agent may be useful as a treatment for
selected patients with premature ejaculation.