Er:YAG Laser Combined With Vaginal Estriol for Genitourinary Syndrome of Menopause

What this trial studies

Chronic hypoestrogenism in postmenopausal women significantly impacts the urogenital epithelium, leading to Genitourinary Syndrome of Menopause (GSM) and increasing susceptibility to gynecological infections due to vaginal pH elevation. Therapies using the Erbium:YAG (Er:YAG) 2940nm laser and low dose topical estrogen have demonstrated efficacy in improving vaginal trophism and restoring microbiota balance. This randomised, double-blind clinical study aims to assess the effects of combining Er: YAG laser therapy with vaginal estriol compared with estriol therapy alone in postmenopausal women with GSM. Sixty patients will be recruited and randomly assigned to two groups.

Conditions in scope

• Genitourinary Syndrome of Menopause

Interventions

• Topical estrogen therapy based on estriol (E3) (Drug) — All participants will use low-dose Vaginal estriol cream (1 mg/g) administered intravaginally using disposable, individualized vaginal applicators pre-set at the recommended dosage of 0.5g/ per application (equivalent to 0.5 mg of estriol per dose). Induction phase: 0.5 g once daily…
• Active Er:YAG Laser (Radiation) — All participants in the group will undergo 3 applications of active Er:YAG laser with an interval of 4-5 weeks between them. The intimate laser session consists of two stages using a PS03 fractional tip: the internal stage (vaginal canal) with…
• Sham Er:YAG laser (minimal fluence) (Radiation) — All participants in the group will undergo 3 sham applications of Sham Er:YAG laser intervention delivered at minimal fluence (0.5 J), below the threshold for biological tissue effect, applied to preserve participant blinding through auditory and procedural cues , with…

Who can join

Women only · Ages 45 Years to 70 Years · Accepts healthy volunteers.

Inclusion criteria

• Postmenopausal women (45-70 years of age).
• At least one of moderate symptom of GSM (vaginal dryness, burning sensation, dyspareunia, and persistent leukorrhea), defined by ≥ 4 on Visual Analog Scale (VAS) ranging from 0 to 10.
• Vaginal pH ≥5.0 at baseline assessment.
• Not having undergone hormone replacement therapy (vaginal or systemic) in the previous six months.
• No use of vaginal moisturizers in the previous 30 days.
• Demonstrated capacity and willingness to provide written informed consent and adhere to study protocols.

Exclusion criteria

• Vaginal or vulvar energy-based interventions (e.g., laser, radiofrequency) in the previous six months.
• Abnormal cervical cytology, specifically ASCUS, LSIL, or HSIL, documented in the previous six months.
• Systemic corticosteroid therapy administered in the previous 90 days.
• Body mass index (BMI) ≥35 kg/m².
• Presence of abnormal uterine bleeding in the previous 30 days.
• History of vaginal surgery in the previous 180 days or grade II or higher uterine prolapse (POP-q).
• History of malignant neoplasms or exposure to vaginal radiotherapy.
• Diagnosis of severe liver or kidney disease, autoimmune disease, or severe psychiatric disorder.

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: 2025-12-10
• Primary completion: 2026-11-10
• Last update posted: 2026-04-23
• First posted: 2025-03-13

Sponsor & contact

Lead sponsor: University of Nove de Julho (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

• Analysis of the Vaginal Health Index (VHI) (Baseline, 30 days after each laser session and 4 months after the third laser application.)
  Clinically assesses the degree of genital atrophy through physical examination, which analyzes "urogenital health." This is useful for the longitudinal follow-up of patients, where changes occurring in the genitourinary tract are noted, including the analysis of the need for therapeutic intervention. The parameters analyzed are: total elasticity, type and consistency of fluid secretion, Vaginal pH, epithelial mucosa, and moisture, which,…

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.