Clinical trial · Interventional
Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial
NCT00981305CI-TRIAL-00028961completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Survivors | — | UNRESOLVED | — |
| Sexual Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lactate-containing vaginal lubricant | Drug | — | UNRESOLVED |
| Placebo vaginal lubricant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lactate-containing Vaginal Lubricant
- description
- apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
- interventionNames
- Drug: Lactate-containing vaginal lubricant
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
- interventionNames
- Drug: Placebo vaginal lubricant
Primary outcomes (1)
- measure
- Change of Pain Score of Female Sexual Function Index
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKim 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