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

Launched by LIAQUAT UNIVERSITY OF MEDICAL & HEALTH SCIENCES · May 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a probiotic called Lactobacillus crispatus M247 (Crispact®) combined with vaginal laser therapy to help menopausal women who have atrophic vulvovaginitis (VVA). VVA can cause uncomfortable symptoms like vaginal dryness, pain during intercourse, and urinary issues. The trial will compare two groups of women: one group will receive only the laser therapy, while the other group will get the laser therapy along with the probiotic. Researchers want to see if the combination helps improve the balance of bacteria in the vagina and reduces symptoms.

To participate in this study, women need to be menopausal for at least a year and experiencing symptoms of VVA or other related urinary issues. They should not have had success with previous estrogen treatments. However, women who are pregnant, breastfeeding, or have certain health conditions or infections will not be eligible. Participants can expect to receive either treatment and will be monitored for changes in their symptoms and overall safety throughout the trial. This study aims to find effective solutions for women struggling with these common menopausal issues.

Gender

FEMALE

Eligibility criteria

• 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.