Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors

Phase 3 Completed 136 enrolled Seoul National University Hospital Medical Research Collaborating Center, Seoul, Korea · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether lactate-containing vaginal lubricant is effective in the treatment of young breast cancer survivors with sexual dysfunction.

Timeline

Start: 2009-09
Primary completion: 2015-07
Completion: 2015-07

Outcome

Missed primary endpoint

paper CONCLUSION: The pH-balanced vaginal gel is not superior to the placebo in improving dyspareunia and overall sexual function. PMID 28383379 ↗

Publications

Kim YH, Park S, Lee M, Hahn S, Jeon MJ. Effect of a pH-Balanced Vaginal Gel on Dyspareunia and Sexual Function in Breast Cancer Survivors Who Were Premenopausal at Diagnosis: A Randomized Controlled Trial. Obstet Gynecol. 2017 May;129(5):870-876. doi: 10.1097/AOG.0000000000001988.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lactate-containing vaginal lubricant	Other / unclassified	3 ml	Other