IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)

Phase 2 Completed 88 enrolled Ixchelsis Limited Carelon Research · collab ICON plc · collab Novotech (Australia) Pty Limited · collab PHT Corporation · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong premature ejaculation.

Timeline

Start: 2014-09
Primary completion: 2015-10
Completion: 2015-10

Outcome

Met primary endpoint

paper The mean increase in IELT from baseline to the last 4 weeks of treatment was 61.0 seconds for cligosiban, which was significantly different PMID 31351659 ↗

paper which was significantly different from (and 3.6-fold greater than) the mean increase of 16.4 seconds for placebo (P = .0086). PMID 31351659 ↗

Publications

McMahon C, Althof S, Rosen R, Giuliano F, Miner M, Osterloh IH, Muirhead GJ, Harty B; PEPIX Multi-Centre Study Group. The Oxytocin Antagonist Cligosiban Prolongs Intravaginal Ejaculatory Latency and Improves Patient-Reported Outcomes in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Trial (PEPIX). J Sex Med. 2019 Aug;16(8):1178-1187. doi: 10.1016/j.jsxm.2019.05.016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cligosiban	Small molecule	800 mg	Oral