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Completed

NCT Number: NCT00981305

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

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.

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Key information

Conditions

Sexual Dysfunction Breast Cancer Survivors Breast Diseases Breast Neoplasms Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Myung Jae, Jeon

Seoul, 110-744, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactate-containing vaginal lubricant

Drug

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 vaginal lubricant

Drug

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

Primary outcomes

  1. Change of Pain Score of Female Sexual Function Index

    Time frame: 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 outcomes

  1. Change of a Total and Other Five Domains of Female Sexual Function Index Score

    Time frame: 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.

  2. Change of Vaginal pH

    Time frame: Baseline and 8 weeks

  3. Change of Vaginal Maturation Index

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Medical Research Collaborating Center, Seoul, Korea

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Sep 22, 2009
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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