NCT00981305

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

Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study scheme * study arm: apply lactate-containing lubricants at the time of sexual intercourse and before sleep at least 3 times per a week for 8 weeks * control arm: placebo apply Outcome measures * Female Sexual function Index (FSFI-20): at 0 wk and at 8 wk * vaginal maturation index: at 0 wk and 8 wk * vaginal pH: at 0 wk and 8 wk

Conditions

• Sexual Dysfunction
• Breast Cancer Survivors

Interventions

Type	Name	Description
DRUG	Lactate-containing vaginal lubricant	vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
DRUG	Placebo vaginal lubricant	vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)

Timeline

• Start date: 2009-09-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2009-09-22
• Last updated: 2017-08-07
• Results posted: 2017-01-26

Locations

1 site across 1 country: South Korea