Effect of a non-hormonal vaginal moisturizer on vaginal and vulvar health in postmenopausal women with breast cancer: A randomized clinical trial.

OBJECTIVE

To evaluate the effectiveness of non-hormonal vaginal moisturizer on vaginal and vulvar health in postmenopausal women with breast cancer.

STUDY

DESIGN

A randomized, open-label trial was conducted in women aged 45-65 years with breast cancer (stages I-III) who had completed oncological treatment (excluding endocrine therapy) and reported vaginal symptoms (vaginal dryness and/or dyspareunia). Participants were randomized into two groups: one group used a vaginal moisturizer (three times per week, at night, n = 50) and the other a vaginal lubricant (during sexual intercourse, n = 50). The 16-week intervention included assessments at baseline, 8, and 16 weeks.

MAIN OUTCOME MEASURES: Vaginal and vulvar health were assessed using the Vaginal Assessment Scale (VAS), Vulvar Assessment Scale (VuAS), Vaginal Health Index (VHI), vaginal pH, and Vaginal Maturation Index (VMI). The primary outcome was improvement in vaginal health as measured by the VHI.

RESULTS

Of the 100 randomized women, 12 discontinued the study (4 in the moisturizer group and 8 in the lubricant group). Adherence to the moisturizer was high (85.9%) and no serious adverse events were reported. At 8 and 16 weeks, the moisturizer group showed significant improvement in VAS (p = 0.014) and VuAS (p = 0.003) scores, as well as a significant increase in VHI scores, indicating improvements in elasticity, moisture, fluid volume, epithelial integrity, and pH (p < 0.0001) compared with the control group. Vaginal pH significantly decreased in the moisturizer group compared with the control group (p = 0.016). No significant between-group differences were observed in VMI scores after 16 weeks (p = 0.213).

CONCLUSIONS

The non-hormonal vaginal moisturizer was effective in improving vaginal and vulvar health parameters in postmenopausal women with breast cancer compared with a vaginal lubricant. Brazilian Clinical Trials Registry (ReBEC,) number RBR-5cf7vzj.