Premature ejaculation (PE) is a widely observed male sexual dysfunction with a major impact on quality of life for many men and their sexual partners.
To assess the safety of tramadol orally disintegrating tablet (ODT) (Zertane) and its efficacy in prolonging intravaginal ejaculation latency time (IELT) and improving Premature Ejaculation Profile (PEP) scores.
Design, setting, and participants
We conducted an integrated analysis of two identical 12-wk randomized double-blind, placebo-controlled phase 3 trials across 62 sites in Europe. Healthy men 18–65 yr of age with a history of lifelong PE according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision, and an IELT ≤120
Subjects were randomized to receive 1:1:1 placebo (n
We measured overall change and fold increase in median IELT and the mean change in all four measures of the PEP. Differences across treatment groups were analyzed using Wilcoxon rank-sum tests, analysis of variance, and chi-square analyses.
Results and limitations
Tramadol ODT resulted in significant increases in median IELT compared with placebo; increases were 0.6
Keywords: Premature ejaculation, Randomized controlled trial, Placebo, Intravaginal ejaculation latency time, Premature ejaculation profile questionnaire, Tramadol.
a Trauma Research Department, Swedish Medical Center, Englewood, CO, USA
b Trauma Research Department, St. Anthony Hospital, Lakewood, CO, USA
c Ampio Pharmaceuticals, Inc., Greenwood Village, CO, USA
Tramadol ODT Study Group: David Bar-Or, Kristin Salottolo, Alessandro Orlando, James Winkler, Kendle International Inc.
© 2011 European Association of Urology, Published by Elsevier B.V.