Clinical Research Directory
Browse clinical research sites, groups, and studies.
Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections
Sponsor: Karo Pharma AB
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.
Official title: 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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-10-20
Completion Date
2027-03-31
Last Updated
2025-11-18
Healthy Volunteers
No
Conditions
Interventions
Multi-Gyn FemiTotal
vaginal gel
Locations (1)
Dr Farah Bolaky
Quatre Bornes, Mauritius