A Phase 3 interventional study of Lactate-containing vaginal lubricant and Placebo vaginal lubricant in Sexual Dysfunction and Breast Cancer Survivors, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-08-07.
Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Treatment
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.
Study scheme
Outcome measures
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This study's enrollment of 136 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Drug: Lactate-containing vaginal lubricant
apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Drug: Placebo vaginal lubricant
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)
Also known as: Clino-san(commercial name in Korea)
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)
Also known as: placebo
Change of Pain Score of Female Sexual Function Index
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.
Time frame: Baseline and 8 weeks
Change of a Total and Other Five Domains of Female Sexual Function Index Score
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.
Time frame: Baseline and 8 weeks
Change of Vaginal pH
Time frame: Baseline and 8 weeks
Change of Vaginal Maturation Index
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).
Time frame: Baseline and 8 weeks
| Milestone | Lactate-containing Vaginal Lubricant | Placebo |
|---|---|---|
| Started | 69 | 67 |
| Completed | 50 | 57 |
| Not completed | 19 | 10 |
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.
| units on a scale | Lactate-containing Vaginal Lubricant | Placebo |
|---|---|---|
| Change of Pain Score of Female Sexual Function Index | 1.15 ± 1.59 | 1.05 ± 1.54 |
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.
| units on a scale | Lactate-containing Vaginal Lubricant | Placebo |
|---|---|---|
| Total | 2.85 ± 4.10 | 3.81 ± 5.10 |
| Desire | 0.19 ± 1.03 | 0.45 ± 0.86 |
| Arousal | 0.42 ± 0.72 | 0.45 ± 0.90 |
| Lubrication | 0.59 ± 1.23 | 0.77 ± 1.50 |
| Orgasm | 0.38 ± 0.81 | 0.67 ± 0.94 |
| Satisfaction | 0.11 ± 0.83 | 0.43 ± 1.06 |
| pH | Lactate-containing Vaginal Lubricant | Placebo |
|---|---|---|
| Change of Vaginal pH | -0.75 ± 0.52 | -0.02 ± 0.59 |
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).
| vaginal maturation index | Lactate-containing Vaginal Lubricant | Placebo |
|---|---|---|
| Change of Vaginal Maturation Index | 4.73 ± 10.37 | 1.00 ± 8.50 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lactate-containing Vaginal Lubricant | — | 0/50 (0%) | 7/50 (14%) |
| Placebo | — | 0/57 (0%) | 7/57 (12.3%) |
| Event | Lactate-containing Vaginal Lubricant | Placebo |
|---|---|---|
| Vaginal itchingReproductive system and breast disorders | 5/50 | 5/57 |
| BothReproductive system and breast disorders | 2/50 | 1/57 |
| Vaginal irritationReproductive system and breast disorders | 0/50 | 1/57 |
| Age, Continuous(years) | Lactate-containing Vaginal Lubricant | Placebo | Total |
|---|---|---|---|
| Mean | 48.6 ± 6.0 | 49.0 ± 5.2 | 48.8 ± 5.6 |
| Sex: Female, Male(Participants) | Lactate-containing Vaginal Lubricant | Placebo | Total |
|---|---|---|---|
| Female | 50 | 57 | 107 |
| Male | 0 | 0 | 0 |
| Parity(pregnancies) | Lactate-containing Vaginal Lubricant | Placebo | Total |
|---|---|---|---|
| Median | 2 (0 to 3) | 2 (0 to 5) | 2 (0 to 5) |
| Body mass index(kg/m^2) | Lactate-containing Vaginal Lubricant | Placebo | Total |
|---|---|---|---|
| Mean | 23.1 ± 2.4 | 23.3 ± 3.3 | 23.2 ± 2.9 |
| Menopause(participants) | Lactate-containing Vaginal Lubricant | Placebo | Total |
|---|---|---|---|
| Yes | 35 | 41 | 76 |
| No | 15 | 16 | 31 |
| Tamoxifen treatment(participants) | Lactate-containing Vaginal Lubricant | Placebo | Total |
|---|---|---|---|
| Yes | 33 | 40 | 73 |
| No | 17 | 17 | 34 |
Plan to share: No
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Seoul National University Hospital