drugset / Trial / NCT04657536

Evaluating the Efficacy of Temperature-controlled Radiofrequency (TRF) in the Treatment of Vulvovaginal Atrophy.

NCT04657536

RandomizedParallel-groupOpen-labelTreatment

Summary

This project will be a prospective, multicenter, randomized cohort study. The investigators will select patients with vulvovaginal atrophy who have indications for treatment, and set up the experimental group (Peninsula temperature-controlled radiofrequency therapeutic apparatus group) and the control group (promestriene vaginal soft capsules group). Changes in vaginal exfoliated cell maturity index (MV), score of vaginal symptoms and signs, vaginal health index score (VHIS), female sexual function index score (FSFI), visual analogue score (VAS) before and after treatment, and adverse effects will be observed to analyze the safety and efficacy of temperature-controlled radiofrequency therapy for vulvovaginal atrophy in postmenopausal women.

Timeline

Start
2020-12-08
Primary completion
2021-12
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Promestriene Other / unclassified 10 mg Other