Clinical trial NCT04657536: Evaluating the Efficacy of Temperature-controlled Radiofrequency (TRF) in the Treatment of Vulvovaginal Atrophy.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postmenopausal Vulvovaginal Atrophy
Keywords: vulvovaginal atrophy
temperature-controlled radiofrequency
postmenopausal woman
Genitourinary Syndrome of Menopause
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Association of Plastics and Aesthetics
First posted: 2020-12-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: The change value of vaginal maturation index (VMI) compared with baseline
timeFrame: The two groups will be visited on day 0, 1 month and 3 months after the last treatment.
measure: the changes of vaginal symptoms and signs scores compared with baseline
timeFrame: The two groups will be visited on day 0, day 20（the control group is day 21），1 month and 3 months after the last treatment.
Secondary outcomes:
measure: The changes of vaginal health index score (VHI) compared with baseline
timeFrame: The two groups will be visited on day 0, day 20（the control group is day 21），1 month and 3 months after the last treatment.
measure: The changes of female sexual function index score (FSFI) compared with baseline
timeFrame: The two groups will be visited on day 0, 1 month and 3 months after the last treatment.
measure: The changes of visual analogue score (VAS) compared with baseline
timeFrame: The two groups will be visited on day 0, day 20（the control group is day 21），1 month and 3 months after the last treatment.
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University People's University
state: Beijing
Study officials:
References: