NCT07234786

Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections

Prospective, Multicentric, Single Arm Clinical Investigation to Assess the Effectiveness and Safety of Multi-Gyn FemiTotal for Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Karo Pharma AB · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the safety and efficacy of Multi-Gyn Femitotal to treat and prevent women suffering from bacterial vaginosis and vulvo vaginal candidiasis. 40 subjects with itching symptoms of VVC and 49 subjects with BV as confirmed using Amsel criteria will be included and will use the device for 7 days (treatment phase). If the VVC symptoms and BV are considered as cured 21 days after the beginning of treatment, the subjects will be followed-up until Month 4 after treatment initiation to check the re-occurrence of VVC and BV (prevention phase).The primary objective is to evaluate the effectiveness of Multi-Gyn FemiTotal for the treatment of Bacterial Vaginosis (BV) and relief of VulvoVaginal Candidiasis (VVC) itching, 21 days after treatment initiation.

Conditions

• Bacterial Vaginosis
• Vaginal Candidiasis

Interventions

Type	Name	Description
DEVICE	Multi-Gyn FemiTotal	vaginal gel

Timeline

• Start date: 2025-10-20
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: Mauritius