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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medical Research Collaborating Center, Seoul, Korea
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00981305
First received: September 20, 2009
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Sexual Dysfunction
Breast Cancer Survivors
 Drug: Lactate-containing vaginal lubricant
Drug: Placebo vaginal lubricant
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • change of FSFI-20 (especially, dyspareunia score) compared with baseline score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change of vaginal pH compared with baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • change of vaginal maturation index compared with baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • adverse effect question [ Time Frame: 8 wks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 118
Study Start Date: September 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Case
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(comercial name in Korea)
Placebo Comparator: Control
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

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
  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981305

Locations
Korea, Republic of
Myong Jae, Jeon
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Medical Research Collaborating Center, Seoul, Korea
Investigators
Principal Investigator: Myong Jae Jeon, MD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00981305     History of Changes
Other Study ID Numbers: SNUH 0905-037-281
Study First Received: September 20, 2009
Last Updated: April 18, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul National University Hospital:
dyspareunia
breast cancer
sexual dysfunction
vaginal lubricant

Additional relevant MeSH terms:
Breast Neoplasms
Sexual Dysfunctions, Psychological
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013