A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation

Summary

The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).

Timeline

Start

2005-03

Primary completion

—

Completion

2006-06

Outcome

Met primary endpoint

paper Dapoxetine treatment significantly prolonged IELT and improved PEP measures and was generally well tolerated in men with PE in the Asia-Pacific region. PMID 19878447 ↗

paper All PEP measures and the CGI of change were significantly improved with dapoxetine vs. placebo at study endpoint (P < or = 0.005 for all). PMID 19878447 ↗

Publications

• McMahon CG, Althof SE, Kaufman JM, Buvat J, Levine SB, Aquilina JW, Tesfaye F, Rothman M, Rivas DA, Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. J Sex Med. 2011 Feb;8(2):524-39. doi: 10.1111/j.1743-6109.2010.02097.x. Epub 2010 Nov 8.
• Porst H, McMahon CG, Althof SE, Sharlip I, Bull S, Aquilina JW, Tesfaye F, Rivas DA. Baseline characteristics and treatment outcomes for men with acquired or lifelong premature ejaculation with mild or no erectile dysfunction: integrated analyses of two phase 3 dapoxetine trials. J Sex Med. 2010 Jun;7(6):2231-2242. doi: 10.1111/j.1743-6109.2010.01820.x. Epub 2010 Apr 19.
• McMahon C, Kim SW, Park NC, Chang CP, Rivas D, Tesfaye F, Rothman M, Aquilina J; Dapoxetine 3003 Study Investigators. Treatment of premature ejaculation in the Asia-Pacific region: results from a phase III double-blind, parallel-group study of dapoxetine. J Sex Med. 2010 Jan;7(1 Pt 1):256-68. doi: 10.1111/j.1743-6109.2009.01560.x. Epub 2009 Oct 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapoxetine	Small molecule	30 mg	Oral
Subject	Dapoxetine	Small molecule	60 mg	Oral

Indications