Status:
COMPLETED
Evaluation of the Efficacy and Safety of Lactobacillus Crispatus M247 (Crispact®) With Vaginal Laser Therapy in Menopausal Women With Atrophic Vulvovaginitis (VVA)
Lead Sponsor:
Liaquat University of Medical & Health Sciences
Collaborating Sponsors:
Università degli Studi dell'Insubria
Conditions:
Atrophic Vulvovaginitis
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief 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 mic...
Detailed Description
Atrophic vulvovaginitis (VVA) is a common condition affecting menopausal women, characterized by symptoms such as vaginal dryness, dyspareunia, itching, and recurrent urinary tract infections. These s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06978907
Start Date
July 1 2025
End Date
December 9 2025
Last Update
January 6 2026
Active Locations (2)
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1
Villa Margherita Clinic
Roma, Italy, 00161
2
Hospital State of Republic of San Marino
San Mariano, Italy, 47893