Phase 3
Completed N=136
Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
sexual dysfunction · Breast Cancer Survivors
Source: ClinicalTrials.gov NCT00981305 ↗
Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Change of Pain Score of Female Sexual Function Index — 1.15; 1.05 units on a scale
◆ Published Evidence
Emerging
15citations · ~2 / year
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.
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.
Linked Publications
-
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Pain Score of Female Sexual Function Index |
1.15; 1.05 | — |
| SECONDARY Change of a Total and Other Five Domains of Female Sexual Function Index Score |
2.85; 3.81; 0.19; 0.45; 0.42; 0.45 | — |
| SECONDARY Change of Vaginal pH |
-0.75; -0.02 | — |
| SECONDARY Change of Vaginal Maturation Index |
4.73; 1.00 | — |
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
Data sourced from ClinicalTrials.gov (NCT00981305) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.