Actively Recruiting
Prospective Multicenter Study to Assess Safety and Effectiveness of Multi-Gyn FemiTotal Vaginal Gel for Treatment and Prevention of Vulvovaginal Candidiasis and Bacterial Vaginosis
Led by Karo Pharma AB ยท Updated on 2025-11-18
80
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- Currently suffering from vulvovaginal candidiasis (VVC) or bacterial vaginosis (BV)
- For VVC: itching score greater than 2 and crumbly white discharge
- For BV: at least 3 of 4 Amsel criteria positive, including presence of clue cells (>20%)
- Provided informed consent
- Using effective contraception (pill, implant, IUD, condoms) for at least 12 weeks before and during the study
- Able and willing to follow study instructions and attend follow-up visits
You will not qualify if you...
- Pregnant, nursing, or planning pregnancy during the study
- Judged non-compliant by the investigator
- Enrolled in another vaginal area clinical trial
- Allergy or hypersensitivity to any component of the device
- Having sexually transmitted or other genital infections or aerobic vaginitis
- Current genital malignancies
- Chemotherapy within 6 months prior to inclusion
- Radiotherapy in genito-urinary area within 12 months prior to inclusion
- Using treatment for vaginal infections or intravaginal treatment at inclusion
- Using antibiotics within 14 days before inclusion
- Using vaginal douches and unwilling to stop during study
- Using a pessary
- Any condition or medication posing undue risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 days
Participants receive the Multi-Gyn FemiTotal vaginal gel for treatment of vulvovaginal candidiasis or bacterial vaginosis.
1 baseline visit and follow-up visits during treatment
Duration - 4 months
Participants are monitored to evaluate prevention of infection re-occurrence after treatment.
1 follow-up visit approximately 4 months after treatment
Trial Site Locations
Total: 1 location
1
Dr Farah Bolaky
Quatre Bornes, Mauritius
Actively Recruiting
Research Team
D
Diana Zeneli, MD
J
Johan Ohlson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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