Non-hormonal vaginal moisturizer improves vaginal health indices in postmenopausal breast cancer survivors

In an open-label randomized clinical trial, 100 postmenopausal women (aged 45-65 years) with breast cancer (stages I-III) who had completed oncological treatment and reported vaginal dryness and/or dyspareunia were assigned to either a non-hormonal vaginal moisturizer used three times per week at night or a vaginal lubricant used during sexual intercourse. The primary outcome was improvement in vaginal health measured by the Vaginal Health Index (VHI), with secondary outcomes including the Vaginal Assessment Scale (VAS), Vulvar Assessment Scale (VuAS), vaginal pH, and Vaginal Maturation Index (VMI).

After 16 weeks of follow-up, the moisturizer group showed statistically significant improvements compared to the lubricant group across several surrogate endpoints: VAS (p = 0.014), VuAS (p = 0.003), VHI (p < 0.0001), and vaginal pH (p = 0.016). No significant between-group difference was found for the VMI (p = 0.213). The study did not report effect sizes, absolute numbers for these outcomes, or data on clinical symptom relief.

Adherence to the moisturizer regimen was high at 85.9%. No serious adverse events were reported. A total of 12 participants discontinued the study (4 in the moisturizer group, 8 in the lubricant group), though adverse event details were not provided. The trial was open-label without a placebo control, using an active comparator (lubricant). Key limitations include the lack of reported effect sizes and absolute outcome numbers, reliance on scale-based surrogate outcomes rather than direct clinical measures, and potential bias from the open-label design.

For clinicians managing postmenopausal breast cancer survivors with vaginal symptoms, this trial provides preliminary evidence that regular use of a non-hormonal vaginal moisturizer may improve certain physiological and self-reported vaginal health indices more than lubricant use alone. However, the absence of placebo comparison, unreported effect magnitudes, and lack of clinical outcome data necessitate cautious interpretation. The findings support considering moisturizers as part of a non-hormonal management strategy, but their superiority for meaningful symptom relief remains uncertain.