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On the Horizon:

Oct. 20, 2004 — Dapoxetine is well tolerated and improves premature ejaculation, according to the results of a phase 2 multicenter, double-blind, randomized, placebo-controlled, 3-phase crossover trial presented at the 11th World Congress of the International Society for Sexual and Impotence Research in Buenos Aires, Argentina.

"Premature ejaculation is a condition that's not often talked about, and by definition it means having ejaculation too early — before a man can control his ejaculation — such that it causes him or his partner some distress," lead investigator Wayne Hellstrom, MD, told Medscape. Dr. Hellstrom is professor of urology at Tulane University Medical Center in New Orleans, Louisiana, and a member of the Medscape Urology editorial advisory board. "[Premature ejaculation is] very common; well recognized studies claim that up to 30% of men suffer from the condition at one time or another," he said.

According to Dr. Hellstrom, an assessment of premature ejaculation based on the woman's use of a stopwatch during intercourse to measure the time elapsed between penetration and ejaculation (intravaginal ejaculatory latency time [IELT]) is more accurate than assessments based on counted thrusts to ejaculation, or estimations of time elapsed. An IELT of fewer than two minutes is considered to be abnormal, or capable of causing distress.

To evaluate the efficacy and tolerability of dapoxetine compared with placebo, Dr. Hellstrom and colleagues randomized 166 male patients aged 23 to 64 years with a baseline IELT of fewer than two minutes (mean, 1.01 minutes) to a series of three crossover treatment periods with dapoxetine 60 mg, dapoxetine 100 mg, and placebo, each separated by 72-hour washout periods. All subjects were involved in a monogamous relationship lasting at least six months; 130 subjects completed the study.

Results of an intent-to-treat analysis showed that dapoxetine 60 mg and 100 mg significantly increased IELT compared with placebo (2.94 minutes for the 60-mg group and 3.20 minutes for the 100-mg group compared with 2.05 minutes for the placebo group; P < .0001 for both).

Nausea was the most commonly reported adverse event, and it occurred with greater frequency in the dapoxetine 100 mg group (16.1%) compared with the dapoxetine 60 mg (5.6%) and placebo (0.7%) groups. 

"There were certain side effects with the higher dose [of dapoxetine], such that 10 patients dropped out of the study — one in the placebo group and 9 in the 100-mg group, mostly due to nausea," noted Dr. Hellstrom. "There were no dropouts in the 60-mg group."

"On the basis of these results — the increase in intravaginal ejaculation time to about three minutes from one minute, and the fact that the 60-mg dose didn't have any adverse effects — Johnson & Johnson decided to use the 60-mg dose in large-scale clinical trials [that are] currently in progress," Dr. Hellstrom said, noting that dapoxetine will likely be available for clinical use in the next six to 12 months.

"As far as quality of life and satisfaction, especially with your partner — I think you're probably going to see studies that come out in the future that look at perception and quality of life, and find less depression, better self-esteem, and improvements in all those kinds of life value parameters in people who have this problem," Dr. Hellstrom noted. "[Premature ejaculation] can cause a lot of distress in a couple, and [dapoxetine therapy] has the potential to help them tremendously."

The investigators report having received funding from Johnson & Johnson, the maker of dapoxetine. 

ISSIR 11th World Congress: Abstract O97. Presented Oct. 21, 2004.

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