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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction; Breast Cancer Survivors
• Intervention / Treatment: Drug: Lactate-containing vaginal lubricant; Drug: Placebo vaginal lubricant

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 Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Myung Jae, Jeon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactate-containing Vaginal Lubricant; apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)	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); Other Names: Clino-san(commercial name in Korea)
Placebo Comparator: Placebo; apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per 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); Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Pain Score of Female Sexual Function Index	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.	Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of a Total and Other Five Domains of Female Sexual Function Index Score	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.	Baseline and 8 weeks
Change of Vaginal pH		Baseline and 8 weeks
Change of Vaginal Maturation Index	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).	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Medical Research Collaborating Center, Seoul, Korea
• Investigators: Principal Investigator: Myung Jae Jeon, MD, Seoul National University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 20, 2009
• First Submitted That Met QC Criteria: September 21, 2009
• First Posted (Estimate): September 22, 2009

Study Record Updates

• Last Update Posted (Actual): August 7, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: breast cancer; sexual dysfunction; dyspareunia; vaginal lubricant
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SNUH 0905-037-281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No