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You have accessJournal of UrologySexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II1 Apr 2017PD69-01 A PHASE IIA STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF THE SELECTIVE OXYTOCIN RECEPTOR ANTAGONIST, IX-01, IN MEN WITH LIFELONG PREMATURE EJACULATION Christopher McMahon, Ian Osterloh, Raymond Rosen, Stanley Althof, Gary Muirhead, Brian Harty, Francois Giuliano, Martin Miner, Bronwyn Stuckey, Marc Gittelman, Laurence Belkoff, Wayne Hellstrom, Allen Seftel, and Irwin Goldstein Christopher McMahonChristopher McMahon More articles by this author , Ian OsterlohIan Osterloh More articles by this author , Raymond RosenRaymond Rosen More articles by this author , Stanley AlthofStanley Althof More articles by this author , Gary MuirheadGary Muirhead More articles by this author , Brian HartyBrian Harty More articles by this author , Francois GiulianoFrancois Giuliano More articles by this author , Martin MinerMartin Miner More articles by this author , Bronwyn StuckeyBronwyn Stuckey More articles by this author , Marc GittelmanMarc Gittelman More articles by this author , Laurence BelkoffLaurence Belkoff More articles by this author , Wayne HellstromWayne Hellstrom More articles by this author , Allen SeftelAllen Seftel More articles by this author , and Irwin GoldsteinIrwin Goldstein More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.3142AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Premature Ejaculation (PE) is associated with rapid ejaculation, inability to delay ejaculation and distress. There are no approved pharmacological treatments in US. The objective was to test the efficacy and safety of IX-01, an orally administered selective oxytocin receptor (OTR) antagonist with potential to treat PE. METHODS A double-blind, placebo-controlled trial (NCT02232425) was performed in US and Australia. Eligibility criteria included lifelong PE, ≥4 intercourse attempts during a 4 week run-in, with intravaginal ejaculatory latency time (IELT) ≤1 minute measured by stopwatch on ≥75% occasions and none > 2 minutes. Men were randomized (2:1) to receive IX-01 or placebo taken 1-6 hours before intercourse during 8 weeks treatment. The starting dose was 400 mg and could be increased to 800 mg or equivalent placebo. Efficacy was assessed by IELT, Clinical Global Impression of Change (CGIC), and Premature Ejaculation Profile (PEP). Safety assessments included adverse events (AEs), vital signs, laboratory tests, electrocardiograms, and depression scales. RESULTS Eighty-six men (mean age 43 years) received ≥1 dose of study drug. Men took a mean of 14.6 (range 1-59) and 13.0 (range 1-51) doses of IX-01 and placebo respectively. Fifty (89.3%) men took the maximum 800 mg dose of IX-01 at least once during the study. The main efficacy results are depicted in Table 1. IX-01 showed clinically and statistically significant improvements in IELT and patient reported outcomes compared to placebo. A summary of the AE′s is presented in Table 2. The AE profile of IX-01 was similar to placebo. No other safety signals were detected. CONCLUSIONS This is the first study to demonstrate the efficacy of an OTR antagonist to treat PE. IX-01 was well tolerated and prolonged IELT, and improved ejaculation control and diminished distress in men with lifelong PE. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e1344 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Christopher McMahon More articles by this author Ian Osterloh More articles by this author Raymond Rosen More articles by this author Stanley Althof More articles by this author Gary Muirhead More articles by this author Brian Harty More articles by this author Francois Giuliano More articles by this author Martin Miner More articles by this author Bronwyn Stuckey More articles by this author Marc Gittelman More articles by this author Laurence Belkoff More articles by this author Wayne Hellstrom More articles by this author Allen Seftel More articles by this author Irwin Goldstein More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...