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

Sexual Dysfunction Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00981305
Study type Interventional
Source Seoul National University Hospital
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 2009
Completion date July 2013
View Details
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