Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
change of FSFI-20 (especially, dyspareunia score) compared with baseline score
8 weeks
No
Myong Jae Jeon, MD
Principal Investigator
Seoul National University Hospital
Korea: Food and Drug Administration
SNUH 0905-037-281
NCT00981305
September 2009
July 2013
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