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Dapoxetine trials
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Dapoxetine (now known as Priligy) has been in development for a number of years, and has undergone Phase III trials in order to get approved for sale in the US and abroad. Some of the results of these Dapoxetine trials are listed below:
The multinational phase III clinical trial enrolled over one thousand men and their female partners from 22 countries (including 16 European countries, Israel, South Africa, Canada, Mexico, Brazil and Argentina) to measure improvement of sexual functioning while taking 30mg or 60mg of Dapoxetine (taken 1 to 3 hours prior to intercourse) versus placebo. Previously reported data showed significant improvements in men with PE treated with Dapoxetine 30mg and 60mg across all measures of PE versus placebo.
The data presented from female partners reinforced the beneficial impact of Dapoxetine treatment, demonstrating significant improvement in all four pre-defined endpoints for partners of men treated with dapoxetine 30mg or 60mg versus placebo over a 25-week period. The four areas (pre-defined endpoints) measured in these Dapoxetine trials are:
* Perception of the Man's control over ejaculation: At baseline, fewer than 5% of women reported that their perception of their partner's control was "good" or "very good". This percentage increased to 24.7% and 32.4% with dapoxetine 30mg and 60mg respectively (vs 14.5% with placebo; p<0.001).
* (Female) distress at timing of partner's ejaculation: More than 42% of women reported that they were "quite a bit" or "extremely" distressed by the timing of their partner's ejaculation at baseline. This decreased to 22.3% and 18.3% with dapoxetine 30mg and 60mg respectively (vs 29.5% with placebo; p<0.001).
* (Female) satisfaction with intercourse: At baseline, fewer than 15% of women reported "good" or "very good" satisfaction with sexual intercourse. This increased to 33.6% and 39.1% with dapoxetine 30mg and 60mg respectively (vs 19.4% with placebo, p<0.01).
* Interpersonal difficulty associated with partner's ejaculation: At baseline, 27.2%, 18.9% and 22.0% of women in the placebo, dapoxetine 30mg and 60mg groups respectively, reported "quite a bit" or "extremely" for the level of interpersonal difficulty associated with their partner's ejaculation. This decreased to 21.2%, 12.5% and 10.7% in the placebo, dapoxetine 30mg and 60mg groups respectively.
Importantly, these findings confirm results from a separate study investigating how premature ejaculation affects female partners, which confirmed the significant impact in terms of lower perceived control over ejaculation, lower satisfaction with sexual intercourse, higher ejaculation-related personal distress and/or interpersonal difficulty in the relationship when compared with female partners of men without PE.
Professor Jacques Buvat, Director of the Centre d'Etude et de Traitement de la Pathologie de l'Appareil Reproducteur et de la Psychosomatique (CETPARP) in Lille, France was the lead author from the phase III Dapoxetine trial, commented on the results, "PE is caused by a combination of physiological and psychological factors, controlled by serotonin signals from the brain, which means that it may be treated with pharmacotherapy. By improving control during sex, Dapoxetine has been shown to help men and their partners experience greater sexual satisfaction, and reduce interpersonal distress."
We determined the efficacy of dapoxetine in a prospectively predefined integrated analysis of two 12-week randomised, double-blind, placebo-controlled, phase III trials of identical design done independently, in parallel, at 121 sites in the USA. Men with moderate-to-severe premature ejaculation in stable, heterosexual relationships took placebo (n=870), 30 mg dapoxetine (874), or 60 mg dapoxetine (870) on-demand (as needed, 1—3 h before anticipated sexual activity). The primary endpoint was intravaginal ejaculatory latency time (IELT) measured by stopwatch. Safety and tolerability were assessed. All analyses were done on an intention-to-treat basis. The trials are registered at ClinicalTrials.gov, numbers NCT00211107 and NCT00211094.
672, 676, and 610 patients completed in the placebo, 30 mg dapoxetine, and 60 mg dapoxetine groups, respectively. Dapoxetine significantly prolonged IELT (p<0·0001, all doses vs placebo). Mean IELT at baseline was 0·90 (SD 0·47) minute, 0·92 (0·50) minute, and 0·91 (0·48) minute, and at study endpoint (week 12 or final visit) was 1·75 (2·21) minutes for placebo, 2·78 (3·48) minutes for 30 mg dapoxetine, and 3·32 (3·68) minutes for 60 mg dapoxetine. Both dapoxetine doses were effective on the first dose. Common adverse events (30 mg and 60 mg dapoxetine, respectively) were nausea (8·7%, 20·1%), diarrhoea (3·9%, 6·8%), headache (5·9%, 6·8%), and dizziness (3·0%, 6·2%).
Results from two large, randomized, placebo-controlled trials presented at EAU demonstrated the relative safety of Dapoxetine. The most common AEs (adverse effects) included nausea, headache, dizziness, and diarrhoea. Most AEs were mild to moderate in severity and did not result in discontinuation from the study.
Both trials showed that treatment with Dapoxetine was not associated with the development of SSRI withdrawal syndrome (a constellation of symptoms including dizziness, gastrointestinal distress, flu-like symptoms, akathisia, sleep disturbances, anxiety, agitation, irritation, aggressive or impulsive behaviour, and others), although the occurrence of generally mild withdrawal symptoms may occur.
Both studies also confirmed that Dapoxetine was not associated with any significant changes in sexual desire or mood (anxiety and depression), measured using validated scales for these effects.
Data from these clinical trials seems to indicate that Dapoxetine will be effective for a good number of men who suffer from premature ejaculation. Over half of all men using Dapoxetine experienced significant improvement in their time to ejaculation. Dapoxetine seems to be well tolerated in most men, with only mild to moderate side effects.
The long term safety of Dapoxetine is not known at this time, and this could be what's holding up FDA approval of Dapoxetine. We encourage you to check back frequently, as we will keep updating this site as new information and progress on Dapoxetine is released. We also encourage you to check out the many effective treatments for PE that are available right now, some of which have proven to be even more effective than Dapoxetine.
Most effective premature ejaculation treatments:
