Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-03 @ 9:10 AM
Study NCT ID:
NCT00981305
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2009-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: