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RECRUITING
NCT07234786
NA

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

Sponsor: Karo Pharma AB

View on ClinicalTrials.gov

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

Interventions

DEVICE

Multi-Gyn FemiTotal

vaginal gel

Locations (1)

Dr Farah Bolaky

Quatre Bornes, Mauritius