Phase 3
N=136
Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
Sexual Dysfunction · Breast Cancer Survivors
Bottom Line
View on ClinicalTrials.gov: NCT00981305 ↗Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Change of Pain Score of Female Sexual Function Index — 1.15; 1.05 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lactate-containing vaginal lubricant (Drug); Placebo vaginal lubricant (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Seoul National University Hospital
- Primary completion
- Jul 2015
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 | — |
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.
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). 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.