Trial · NCT00981305
Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
NCT00981305, Phase 3, Completed, Seoul National University Hospital; results first posted 2017-01-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors. Trials, record NCT00981305. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00981305
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
- NCT number
- NCT00981305
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 136 participants, actual
- Lead sponsor
- Seoul National University Hospital
- Conditions
- Sexual Dysfunction, Breast Cancer Survivors
- Interventions
- Lactate-containing vaginal lubricant, Placebo vaginal lubricant
- First posted
- 2009-09-22
- Last updated
- 2017-08-07
- Results first posted
- 2017-01-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of Pain Score of Female Sexual Function Index | Baseline and 8 weeks | 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. |
| Secondary | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Baseline and 8 weeks | 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. |
| Secondary | Change of Vaginal pH | Baseline and 8 weeks | |
| Secondary | Change of Vaginal Maturation Index | Baseline and 8 weeks | 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). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change of Pain Score of Female Sexual Function Index | Baseline and 8 weeks | units on a scale | MEAN | |
| SECONDARY | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Baseline and 8 weeks | units on a scale | MEAN | |
| SECONDARY | Change of Vaginal pH | Baseline and 8 weeks | pH | MEAN | |
| SECONDARY | Change of Vaginal Maturation Index | Baseline and 8 weeks | vaginal maturation index | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change of Pain Score of Female Sexual Function Index | Lactate-containing Vaginal Lubricant | 1.15 | Standard Deviation 1.59 | units on a scale | |
| Change of Pain Score of Female Sexual Function Index | Placebo | 1.05 | Standard Deviation 1.54 | units on a scale | |
| Change of a Total and Other Five Domains of Female Sexual Function Index Score | Lactate-containing Vaginal Lubricant | Total | 2.85 | Standard Deviation 4.10 | units on a scale |
| Change of a Total and Other Five Domains of Female Sexual Function Index Score | Placebo | Total | 3.81 | Standard Deviation 5.10 | units on a scale |
| Change of a Total and Other Five Domains of Female Sexual Function Index Score | Lactate-containing Vaginal Lubricant | Desire | 0.19 | Standard Deviation 1.03 | units on a scale |
| Change of a Total and Other Five Domains of Female Sexual Function Index Score | Placebo | Desire | 0.45 | Standard Deviation 0.86 | units on a scale |
| Change of a Total and Other Five Domains of Female Sexual Function Index Score | Lactate-containing Vaginal Lubricant | Arousal | 0.42 | Standard Deviation 0.72 | units on a scale |
| Change of a Total and Other Five Domains of Female Sexual Function Index Score | Placebo | Arousal | 0.45 | Standard Deviation 0.90 | units on a scale |
| Change of a Total and Other Five Domains of Female Sexual Function Index Score | Lactate-containing Vaginal Lubricant | Lubrication | 0.59 | Standard Deviation 1.23 | units on a scale |
| Change of a Total and Other Five Domains of Female Sexual Function Index Score | Placebo | Lubrication | 0.77 | Standard Deviation 1.50 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lactate-containing Vaginal Lubricant | 69 | |
| Overall Study | STARTED | Placebo | 67 | |
| Overall Study | COMPLETED | Lactate-containing Vaginal Lubricant | 50 | |
| Overall Study | COMPLETED | Placebo | 57 | |
| Overall Study | NOT COMPLETED | Lactate-containing Vaginal Lubricant | 19 | |
| Overall Study | NOT COMPLETED | Placebo | 10 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vaginal itching | Reproductive system and breast disorders | Lactate-containing Vaginal Lubricant | 5 | 50 | |
| other | Vaginal itching | Reproductive system and breast disorders | Placebo | 5 | 57 | |
| other | Vaginal irritation | Reproductive system and breast disorders | Lactate-containing Vaginal Lubricant | 0 | 50 | |
| other | Vaginal irritation | Reproductive system and breast disorders | Placebo | 1 | 57 | |
| other | Both | Reproductive system and breast disorders | Lactate-containing Vaginal Lubricant | 2 | 50 | |
| other | Both | Reproductive system and breast disorders | Placebo | 1 | 57 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lactate-containing Vaginal Lubricant | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Lactate-containing Vaginal Lubricant | 7 | 50 |
| Total, other adverse events | Placebo | 7 | 57 |
| Total, serious adverse events | Lactate-containing Vaginal Lubricant | 0 | 50 |
| Total, serious adverse events | Placebo | 0 | 57 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28383379 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lactate-containing Vaginal Lubricant vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00981305
GET https://conductscience.org/api/trials/v1/NCT00981305/registered