Investigational PE Rx improves QoL in men, partners

May 20, 2008

Dapoxetine, a drug currently under investigation for the treatment of premature ejaculation, provides significant improvement in the sexual function of men and their sexual partners, according to the results of a recent multinational study presented here.

Dapoxetine, a drug currently under investigation for the treatment of premature ejaculation, provides significant improvement in the sexual function of men and their sexual partners, according to the results of a recent multinational study presented here.

In the 22-country, 25-week, phase III clinical trial, more than 1,000 men and their female partners were recruited and randomized to receive either 30 mg or 60 mg of dapoxetine or placebo to be taken on demand 1 to 3 hours prior to sexual intercourse. Improvement in their sexual functioning was recorded.

Results showed that, compared to baseline, there was a significant and dose-dependent improvement in the sexual experience and psychological experience among the female partners of the men receiving dapoxetine. This improvement included the perceived control over ejaculation by the man, what confirmed the reality of the improvement in the man, as well as the satisfaction with sexual intercourse experienced by the female partner. Distress related to PE among the women and their interpersonal difficulties within the relationship also were significantly improved from baseline.

"This is probably the first study that has considered the effects/the benefits of pharmacologic treatment of PE on the female partner," lead author Jacques Buvat, MD, of the Centre d'Etude et de Traitement de la Pathologie de l'Appareil Reproducteur et de la Psychosomatique in Lille, France. "Several recent studies based on specially designed questionnaires have shown the negative impact of PE on the partner is very important, and probably as important as in the male."

At baseline, less than 5% of female participants reported that their male partner's control over ejaculation was "good" or "very good." At the end of the study, this percentage increased to 25% and 32.3% with dapoxetine, 30 mg and 60 mg, respectively (vs. 14.4% with placebo). In addition, less than 16% of female partners reported "good" or "very good" satisfaction with sexual intercourse at baseline. This percentage increased at the end of the study to 33.8% and 39.1% for female partners of men who received dapoxetine, 30 mg and 60 mg, respectively (vs. 19.4% with placebo).

Dr. Buvat is an adviser and investigator for Johnson & Johnson.