NCT04657536

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

Randomized Multicenter Clinical Trial for Evaluating the Efficacy of Temperature-controlled Radiofrequency Compared With Topical Estriol in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postmenopausal Vulvovaginal Atrophy

Interventions

Type	Name	Description
DEVICE	high frequency fulguration equipment	All subjects will be carried out with 3 standard protocol TRF treatments to the vulvovaginal tissue using the high frequency fulguration equipment (Shenzhen Peninsula Medical co., Ltd) at 10-day to 15-day intervals. Radiofrequency energy was applied to the vaginal canal through a specialized probe combining monopolar and bipolar treatment modes. Monopolar treatment mode is for 15 minutes. Aim the three indication points A, B and C on the probe to the direction of 12 o'clock in turn. Each area should be treated for about 5 minutes. Rotate the probe clockwise when changing the area for treatment.Bipolar treatment mode is for 10 minutes. Firstly, indication point A is aimed to 12 o'clock for 5-minutes treatment and then the probe is rotated 90°clockwise for another 5-minutes treatment. The power setting will be 35-40w, and the target temperature setting will be 40 to 45℃, titrated to subject tolerance.
DRUG	promestriene vaginal soft capsules	Promestriene vaginal soft capsules（Zhejiang Anbao Pharmaceutical Co. LTD）will be used 10mg once a day for continuous 20 days.

Timeline

• Start date: 2020-12-08
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-12-08
• Last updated: 2021-03-22

Locations

1 site across 1 country: China