Trial | NCT04657536  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    200
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.
Study Started
Dec 08
2020
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
Mar 22
2021

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.

  • Other names: temperature controlled radiofrequency

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.

  • Other names: Estriol

TRF group Experimental

the group who treated with temperature controlled radiofrequency

Estriol group Active Comparator

the group who treated with promestriene vaginal soft capsules

Criteria 

Inclusion Criteria:

Menopausal time at least one year.
Genitourinary Syndrome of Menopause (GSM) related symptoms with moderate or severe intensity, such as dryness and dyspareunia, etc.
Blood FSH≥30 IU/L (30mIU/mL)。
Clinical symptoms and signs of vaginal atrophy score≥15.
Breast ultrasound examination was grade 1-3 within 9 months before the study.
Voluntary participation in clinical trials and signed informed consent.
Patients followed the treatment regimen and completed the study.

Exclusion Criteria (one of the following criteria is excluded) :

The patients who did not meet the inclusion criteria
Received Estrogen replacement therapy (including local and systemic medication) within 3 months.
Received any medicine (such as Baofukang suppository) to treat vulvovaginal atrophy within 3 months.
Corticosteroids were used within 6 weeks. Long-term corticosteroids were used (intermittent nasal or skin application, eye drops and ears are allowed).
Other experimental drugs were used within 1 month.
Received vaginal laser therapy within 6 months.
Patients with acute urinary tract infection;
Patients with acute genital tract infection (genital herpes, trichomonad, fungal vaginitis; gonococcus, mycoplasma, chlamydia infection and bacterial vaginosis, etc.);
Patients with pelvic organ prolapse greater than or equal to stage II;
Patients with metal intrauterine device (IUD)；
Patients with precancerous lesions or malignant tumors of vagina and cervix;
Patients with serious heart, liver, brain, kidney, endocrine diseases, etc.
Allergic to control drug and excipients.
Other malignancies are known or suspected.
With estrogen-dependent neoplasm.
Confirm a history of depression or serious mental illness.
There were consciousness barriers and communication barriers that could not cooperate with the experiment.
Patients considered unsuitable for this clinical trial.
No Results Posted