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

Phase 3

Completed

• Conditions: Sexual Dysfunction; Breast Cancer Survivors
• Interventions: Drug: Lactate-containing vaginal lubricant; Drug: Placebo vaginal lubricant

• Registration Number: NCT00981305
• Lead Sponsor: Seoul National University Hospital

Brief 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

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-20
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-10
• Results First Submitted: 2016-10-09
• Results First Submitted QC: 2016-12-01
• Results First Posted: 2017-01-26
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactate-containing Vaginal Lubricant	Lactate-containing vaginal lubricant	apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Placebo	Placebo vaginal lubricant	apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)

Primary Outcome Measures

Name	Time	Method
Change of Pain Score of Female Sexual Function Index	Baseline and 8 weeks	The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.

Secondary Outcome Measures

Name	Time	Method
Change of a Total and Other Five Domains of Female Sexual Function Index Score	Baseline and 8 weeks	The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.
Change of Vaginal pH	Baseline and 8 weeks
Change of Vaginal Maturation Index	Baseline and 8 weeks	Vaginal maturation index is a ratio obtained by performing a random cell count of the three major cell types shed from the vaginal squamous epithelium: parabasal, intermediate, and superficial cells. The higher the maturation index, the higher the number of mature cells (those designated superficial and intermediate).

Trial Locations

Locations (1)

Myung Jae, Jeon; 🇰🇷 Seoul, Korea, Republic of