Evaluation of the Efficacy and Safety of Lactobacillus Crispatus M247 (Crispact®) With Vaginal Laser Therapy in Menopausal Women With Atrophic Vulvovaginitis (VVA)

What this trial studies

This randomized, controlled, prospective, multicenter study aims to evaluate the efficacy and safety of Lactobacillus crispatus M247 in combination with vaginal laser therapy for improving vaginal microbiota composition and reducing genitourinary symptoms in menopausal women with atrophic vulvovaginitis (VVA). Participants will be randomized into two groups: one receiving laser therapy alone and the other receiving laser therapy combined with daily administration of the probiotic Lactobacillus crispatus M247 (Crispact®). Primary outcomes include changes in genitourinary symptoms assessed using a validated vulvovaginal symptom questionnaire and evaluation of safety. Secondary outcomes include changes in vaginal microbiota composition.

Conditions in scope

• Atrophic Vulvovaginitis

Interventions

• Monnalisa Touch® Laser Therapy (Device) — Monnalisa Touch® laser therapy is a non-ablative fractional CO2 laser applied to the vaginal mucosa to promote tissue regeneration and maintain vaginal health. Participants in this group will receive three sessions of laser therapy, one session every 30 days.
• Monnalisa Touch® Laser Therapy + Lactobacillus crispatus M247 (Crispact®) (Combination Product) — Participants in this group will receive three sessions of Monnalisa Touch® laser therapy, one session every 30 days, along with daily administration of Lactobacillus crispatus M247 (Crispact®), a probiotic containing 20 billion CFU, taken orally for three months.

Who can join

Women only · Ages 40 Years and up

Inclusion criteria

• Menopausal women with no menstrual cycle for \>12 months.
• Diagnosed with atrophic vulvovaginitis (VVA) and experiencing related symptoms (vaginal dryness, introital and profound dyspareunia, itching, burning, bleeding during intercourse).
• Symptoms related to genitourinary syndrome of menopause (GSM), including urinary urgency, increased frequency, nocturia, recurrent cystitis, or post-coital cystitis.
• Prior negative PAP test performed within one year of enrollment.
• Women who are unresponsive to or dissatisfied with prior topical estrogen therapy or who have contraindications to local and/or systemic estrogen prescription.

Exclusion criteria

• Pregnancy or breastfeeding.
• Presence of preneoplastic or neoplastic lesions of the cervix, vagina, or vulva.
• Active genital and/or urinary tract infections.
• Dermatological contraindications to laser therapy.
• Ongoing systemic or local hormone therapy.
• Neurological or psychiatric disorders.
• Chronic systemic diseases of autoimmune or dysmetabolic nature.

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: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2025-07-01
• Primary completion: 2025-11-27
• Last update posted: 2026-01-06
• First posted: 2025-05-18

Sponsor & contact

Lead sponsor: Liaquat University of Medical & Health Sciences (Other)

Collaborators: Università degli Studi dell'Insubria

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

• Change in Genitourinary Symptoms (Baseline (T0) to Month 3 (M3).)
  Assessment using the Vulvovaginal Atrophy Symptom Questionnaire (VASQ), evaluating symptom severity (e.g., vaginal dryness, itching, dyspareunia, urinary symptoms) from baseline (T0) to Month 3 (M3).
• Safety Assessment (Baseline (T0) to Month 3 (M3).)
  Evaluation of safety and tolerability of Lactobacillus crispatus M247 based on the incidence of adverse events throughout the study period (Baseline to Month 3).

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.