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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunction Breast Cancer Survivors Drug: Lactate-containing vaginal lubricant Drug: Placebo vaginal lubricant Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial
Study Start Date : September 2009
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

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Arms and Interventions
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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 Name: 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 Name: placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981305


Locations
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Korea, Republic of
Myung Jae, Jeon
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Medical Research Collaborating Center, Seoul, Korea
Investigators
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Principal Investigator: Myung Jae Jeon, MD Seoul National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00981305    
Other Study ID Numbers: SNUH 0905-037-281
First Posted: September 22, 2009    Key Record Dates
Results First Posted: January 26, 2017
Last Update Posted: August 7, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Seoul National University Hospital:
dyspareunia
breast cancer
sexual dysfunction
vaginal lubricant
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases