Overview

This trial is active, not recruiting.

Conditions sexual dysfunction, breast cancer survivors
Treatments lactate-containing vaginal lubricant, placebo vaginal lubricant
Phase phase 3
Sponsor Seoul National University Hospital
Collaborator Medical Research Collaborating Center, Seoul, Korea
Start date September 2009
End date July 2013
Trial size 118 participants
Trial identifier NCT00981305, SNUH 0905-037-281

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
lactate-containing vaginal lubricant Clino-san(comercial name in Korea)
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)
(Placebo Comparator)
apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
placebo vaginal lubricant placebo
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)

Primary Outcomes

Measure
change of FSFI-20 (especially, dyspareunia score) compared with baseline score
time frame: 8 weeks

Secondary Outcomes

Measure
change of vaginal pH compared with baseline
time frame: 8 weeks
change of vaginal maturation index compared with baseline
time frame: 8 weeks
adverse effect question
time frame: 8 wks

Eligibility Criteria

Female participants from 20 years up to 60 years old.

Inclusion Criteria: - breast cancer survivors over 20 years-old - premenopausal at the time of diagnosis - treated with operation and chemotherapy - newly developed dyspareunia after cancer treatment Exclusion Criteria: - recent (< 2 months) start or cessation of hormonal treatment (tamoxifen etc.) - depression or other psychological problems - active vaginal infection - evidence of cancer recurrence - previously use of lactate-containing lubricants - other chronic diseases which severely disturb the sexual life

Additional Information

Official title Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial
Principal investigator Myong Jae Jeon, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.