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

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ClinicalTrials.gov Identifier: NCT00981305
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : January 26, 2017
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
Medical Research Collaborating Center, Seoul, Korea
Information provided by (Responsible Party):
Seoul National University Hospital

September 20, 2009
September 22, 2009
October 9, 2016
January 26, 2017
August 7, 2017
September 2009
July 2015   (Final data collection date for primary outcome measure)
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.
change of FSFI-20 (especially, dyspareunia score) compared with baseline score [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT00981305 on ClinicalTrials.gov Archive Site
  • 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.
  • Change of Vaginal pH [ Time Frame: Baseline and 8 weeks ]
  • 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).
  • 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 ]
Not Provided
Not Provided
 
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 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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Sexual Dysfunction
  • Breast Cancer Survivors
  • 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 Name: Clino-san(commercial name in Korea)
  • 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 Name: placebo
  • 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)
    Intervention: Drug: Lactate-containing vaginal lubricant
  • Placebo Comparator: Placebo
    apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
    Intervention: Drug: Placebo vaginal lubricant
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
118
July 2015
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
20 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00981305
SNUH 0905-037-281
Yes
Not Provided
Plan to Share IPD: No
Seoul National University Hospital
Seoul National University Hospital
Medical Research Collaborating Center, Seoul, Korea
Principal Investigator: Myung Jae Jeon, MD Seoul National University Hospital
Seoul National University Hospital
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP