Study to Evaluate the Safety and Effectiveness of Multi-Gyn FemiTotal Vaginal Gel for Treating and Preventing Bacterial Vaginosis and Vaginal Candidiasis in Women

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Multi-Gyn FemiTotal, a vaginal gel, for treating and preventing bacterial vaginosis BV and vulvovaginal candidiasis VVC in women. This study includes 40 women with VVC itching symptoms and 49 women with BV confirmed by Amsel criteria. The main goal is to assess how well the gel relieves itching and treats BV and VVC symptoms 21 days after starting treatment. Participants will use the Multi-Gyn FemiTotal vaginal gel for 7 days during the treatment phase. If symptoms are considered cured 21 days after treatment begins, they will enter a prevention phase with follow-up visits up to 4 months after starting treatment to monitor for any recurrence of BV or VVC. This is a single-arm, multicenter clinical investigation. During the study, participants will be assessed by doctors and complete questionnaires to evaluate symptom relief and treatment effectiveness at 21 days. Follow-up evaluations at 4 months will check for the prevention of BV and VVC recurrence. Participants will also be monitored for safety and adherence to the treatment and follow-up schedule. The total study duration for each participant includes treatment and extended follow-up for up to 4 months.

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