Dapoxetine in men with premature ejaculation and erectile dysfunction

• Research type

  Research Study

• Full title

  A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Dapoxetine in Men With Premature Ejaculation and Concomitant Erectile Dysfunction Treated With a Phosphodiesterase-5 Inhibitor COUPLE: COncomitant Use of PriLigy in Men Treated for Erectile Dysfunction

• IRAS ID

  37395

• Contact name

  Geoff Hackett

• Sponsor organisation

  Janssen Cilag International N.V.

• Eudract number

  2009-013616-12

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Premature ejaculation (PE)in men with underlying erection problems affects a substantial number of men. The standard treatment for erection problems is the use of drugs called PDE-5 inhibitors (for example, Viagra, Cialis and Levitra). At present it is not clear whether adding the new drug dapoxetine in men whose underlying erectile dysfunction (ED) has been successfully treated will improve their symptoms of premature ejaculation. Dapoxetine is the only drug in its class which can be used on an "as needed" basis. Dapoxetine, when administered 1 to 3 hours before anticipated intercourse, is generally well tolerated and results in a significant improvement in the time to ejaculation in men with PE. The primary aim of the current study is to assess the effectiveness of 12 weeks treatment with one of two doses of dapoxetine (taken on an "as needed" basis) compared to placebo (dummy treatment) in prolonging the time to ejaculation in men with PE and ED who are already being treated with a PDE-5 inhibitor. A total of approximately 656 men will take part in a number of study sites internationally.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/21

• Date of REC Opinion

  6 Apr 2010

• REC opinion

  Favourable Opinion