Clinical Trial

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

Completed
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-11; most recent amendment 2026-01-03.
Status change: Not Yet Recruiting → Completed 2026-01-03
Trial Details
NCT Number NCT06978907
Lead Sponsor Liaquat University of Medical & Health Sciences
Collaborators: Università degli Studi dell'Insubria
Conditions Atrophic Vulvovaginitis
Enrollment 75 participants
Start Date 2025-07-01
Primary Completion 2025-11-27 (estimated)
Study Completion 2025-12-09 (estimated)
Updated on ClinicalTrials.gov 2026-01-06