NCT00981305 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2017-08-07

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Change of Pain Score of Female Sexual Function Index

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outcome · POSTED

Change of a Total and Other Five Domains of Female Sexual Function Index Score

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outcome · POSTED

Change of Vaginal pH

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outcome · POSTED

Change of Vaginal Maturation Index

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
maximum Age: 60 Years
minimum Age: 20 Years
sex: FEMALE
std Ages: ADULT

Treatment arms and interventions

arm Groups

description
apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
intervention Names
Drug: Lactate-containing vaginal lubricant
label
Lactate-containing Vaginal Lubricant
type
EXPERIMENTAL
description
apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
intervention Names
Drug: Placebo vaginal lubricant
label
Placebo
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Lactate-containing Vaginal Lubricant
description
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)
name
Lactate-containing vaginal lubricant
other Names
Clino-san(commercial name in Korea)
type
DRUG
arm Group Labels
Placebo
description
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)
name
Placebo vaginal lubricant
other Names
placebo
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 136
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.
measure
Change of Pain Score of Female Sexual Function Index
time Frame
Baseline and 8 weeks

secondary Outcomes

description
The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.
measure
Change of a Total and Other Five Domains of Female Sexual Function Index Score
time Frame
Baseline and 8 weeks
measure
Change of Vaginal pH
time Frame
Baseline and 8 weeks
description
Vaginal maturation index is a ratio obtained by performing a random cell count of the three major cell types shed from the vaginal squamous epithelium: parabasal, intermediate, and superficial cells. The higher the maturation index, the higher the number of mature cells (those designated superficial and intermediate).
measure
Change of Vaginal Maturation Index
time Frame
Baseline and 8 weeks

Full study description

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

Source references

references

citation
Kim YH, Park S, Lee M, Hahn S, Jeon MJ. Effect of a pH-Balanced Vaginal Gel on Dyspareunia and Sexual Function in Breast Cancer Survivors Who Were Premenopausal at Diagnosis: A Randomized Controlled Trial. Obstet Gynecol. 2017 May;129(5):870-876. doi: 10.1097/AOG.0000000000001988.
pmid
28383379
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-a1d4f1a0da25422b0d38
requested nct id
NCT00981305
primary nct id
NCT00981305
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Vaginal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
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payload
clinical indication matching status
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end exclusive
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id
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link basis
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nct id
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occurrences
context exact
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end
11
exact text
NCT00981305
start
0
offset unit
unicode_code_points
query cond
Vaginal Cancer
query disease state id
ds-vaginal-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-vaginal-cancer-000.json
source file sha256
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source json pointer
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source kind
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source record id
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source string basis
parsed_JSON_string_unmodified
source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Vaginal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice