Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Dyspareunia

Breast Diseases

Skin Diseases

apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)

apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)

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)

Lactate-containing 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)

Placebo vaginal lubricant

Myung Jae Jeon, MD

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 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

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 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.

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).

Medical Research Collaborating Center, Seoul, Korea

Seoul National University Hospital

apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)

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)

Lactate-containing Vaginal Lubricant

apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)

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)

Spots Global Cancer Trial Database for Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors

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