drugset / Trial / NCT05651087

Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment in Breast Cancer Patient

NCT05651087 ↗

Unknown 60 enrolled Gun Oh Chong
RandomizedParallel-groupOpen-labelTreatment

Summary

Adjuvant hormone treatments for early breast cancer are associated with frequent bothersome side effects with major negative impact on patients' quality of life and treatment adherence. Patients most commonly report menopausal symptoms including vaginal dryness, vaginal bleeding, and dyspareunia. Even though previous studies have reported that estrogen topical agent relives these symptoms, non-hormonal therapy should be considered first due to concerns about the role of estrogen in breast cancer development. Therefore, this trial is planned to evaluate the efficacy and safety of LacuD (hyaluronic acid, lactic acid and alginate) in the vaginal environment of breast cancer patients receiving hormone therapy.

Timeline

Start
2022-12-20
Primary completion
2023-02-28
Completion
2023-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject LACUDY Unknown 2 ml Other