Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction

Phase 3 Completed 495 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to placebo in men with premature ejaculation and erectile dysfunction who are currently being treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for erectile dysfunction.

Timeline

Start: 2010-04
Primary completion: 2011-08
Completion: 2011-09

Outcome

Met primary endpoint

paper Arithmetic mean average IELT significantly increased with dapoxetine vs. placebo at end point (5.2 vs. 3.4 minutes) PMID 23845016 ↗

Publications

McMahon CG, Giuliano F, Dean J, Hellstrom WJ, Bull S, Tesfaye F, Sharma O, Rivas DA, Aquilina JW. Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study. J Sex Med. 2013 Sep;10(9):2312-25. doi: 10.1111/jsm.12236. Epub 2013 Jul 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapoxetine	Small molecule	30 mg	Oral
Subject	Dapoxetine	Small molecule	60 mg	Oral
Background	Sildenafil	Unknown	—	—
Background	Tadalafil	Small molecule	—	—
Background	Vardenafil	Small molecule	—	—