Status:
COMPLETED
Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Medical Research Collaborating Center, Seoul, Korea
Conditions:
Sexual Dysfunction
Breast Cancer Survivors
Eligibility:
FEMALE
20-60 years
Phase:
PHASE3
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00981305
Start Date
September 1 2009
End Date
July 1 2015
Last Update
August 7 2017
Active Locations (1)
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1
Myung Jae, Jeon
Seoul, South Korea, 110-744