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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014