Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

This Phase III, randomized, balanced, parallel-group, multicenter trial aims to evaluate the effect of vaginal radiofrequency on symptoms of vaginal dryness at six months. The study compares vaginal radiofrequency treatment with non-hormonal hydration therapy in a population of patients undergoing adjuvant hormonal therapy with aromatase inhibitors, with or without LHRH agonists, for breast cancer.

Patients will be randomly assigned to one of two parallel treatment groups until the six-month assessment:

The first group will receive the reference treatment, which consists of local hydration using a hyaluronic acid-based treatment applied three times a week. Additionally, investigators may incorporate supportive measures at their discretion, such as physiotherapy or vaginal dilators.

The second group will receive the same reference treatment combined with vaginal radiofrequency therapy. This intervention consists of three sessions, each spaced 4 to 6 weeks apart.