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

Peking University

Status: Unknown

Conditions: Postmenopausal Vulvovaginal Atrophy

Treatments: Device: high frequency fulguration equipment; Drug: promestriene vaginal soft capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT04657536

Version 2.0；20200221

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

TRF group

Experimental group

Description:

the group who treated with temperature controlled radiofrequency

Treatment:

Device: high frequency fulguration equipment

Estriol group

Active Comparator group

Description:

the group who treated with promestriene vaginal soft capsules

Treatment:

Drug: promestriene vaginal soft capsules