LASER and Radiofrequency and Genitourinary Syndrome of Menopause

What this trial studies

This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic strogen to treat symptoms of vulvovaginal atrophy of post menopause.

Conditions in scope

• Postmenopausal Atrophic Vaginitis
• Postmenopausal Symptoms
• Genitourinary Symptoms

Interventions

• LASER (Procedure) — Use of the SmartXide Touch V²LR, Co2 Laser System to perform ambulatory intravaginal and vulvar application of LASER, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia,…
• Microablative Radiofrequency (Procedure) — Use of Linly™ equipment to perform ambulatory intravaginal and vulvar application of fractionated microablative radiofrequency, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the radiofrequency will…
• Estriol (Drug) — The patient will perform self application of this vaginal estriol daily for 2 weeks and after that the applications will occur twice a week.

Who can join

Women only · Ages 40 Years to 65 Years

Inclusion criteria

• Women between 2 and 5 years after menopause, without hormone therapy for at least 2 years
• To present, at least moderate, or severe intensity (score 4 or more of visual analog scale ( 0-10)) of one of the signs or symptoms of of vulvovaginal atrophy:
• Burning
• Discomfort
• Dryness
• Cracks
• Pruritus
• Lack of vaginal lubrication

Exclusion criteria

• Active genital infection, active infection of HPV (human papillomavirus) or Herpes, users of medications with estrogenic effect (digoxin, tamoxifen and other chemicals)
• Postmenopausal genital bleeding, uncontrolled diabetes, use of multivitamins with zinc, use of copper or hormonal IUDs (intrauterine device) at the time of inclusion, presence of genitourinary or rectovaginal fistulas.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2019-08-05
• Primary completion: 2025-08
• Last update posted: 2025-04-22
• First posted: 2019-08-05

Sponsor & contact

Lead sponsor: Federal University of São Paulo (Other)

Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Clinical Improvement of signs and symptoms postmenopausal genitourinary syndrome with intravaginal LASER, Microablative Radiofrequency, and topic estriol (The evaluation will be done 180 days after treatment)
  Will be applied a Visual Analogic Scale (0-10) to access the improvement of genitourinary signs and symptoms, the results of the three groups will be compared
• Satisfaction of postmenopausal women with genitourinary syndrome with the treatment by intravaginal LASER, Micro ablative Radiofrequency, and topic estriol (The evaluation will be done 180 days after treatment)
  Will be applied a LIKERT Satisfaction Scale (1-5) to access the satisfaction with the treatment, the results of the three groups will be compared

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.