Efficacy of Fractional CO2 Laser Treatment in Post-Menopausal Women With Vaginal Atrophy

What this trial studies

Vaginal dryness, itching, burning, irritability, secretion, and various urinary problems are the symptoms of vulvovaginal atrophy. Therefore, more attention must be paid to relieve these symptoms in order to provide better sexual health for postmenopausal women. At present, an accumulating body of evidence suggests safety and efficacy of laser and energy-based devices for the treatment of women's genitourinary conditions. More clinical studies are needed to assess the safety profile and clinical outcomes of the lasers and energy-based devices to treat the symptoms associated with vulvovaginal atrophy (VVA)

Conditions in scope

• Post Menopausal Vaginal Atrophy

Interventions

• Fractional CO2 laser (Device) — . Using the following settings with the internal handpiece: square pattern with Deep Mode, fractional density of 5% and energy level of 50 mJ and fluence of 283 J/cm2. The handpiece will be inserted into the vagina (up to 10…

Who can join

Women only · Ages 45 Years to 65 Years

Inclusion criteria

• Menopausal women whose ages ranged from 45 to 65 years.
• Sexually active
• Had symptoms of VVA (vaginal dryness, irritation, soreness, or dyspareunia)

Exclusion criteria

• Any history of hormonal therapy within the past 6 months
• Vaginal moisturizer or lubricant applications within the past 30 days
• Acute/recurrent urinary tract infection
• Active genital infection
• Prolapse stage II or more based on examination
• Psychiatric disorders
• Undiagnosed vaginal bleeding
• Any serious disease or chronic condition that could interfere with study compliance

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: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2023-10-01
• Primary completion: 2025-03-01
• Last update posted: 2024-12-10
• First posted: 2024-12-10

Sponsor & contact

Lead sponsor: Cairo University (Other)

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

• The Vulvovaginal Symptoms Questionnaire (VVSQ) (4-6 months)
• The Vaginal Health Index VHI assessment. (4-6 months)

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.