Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections (NCT07234786) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections
Mauritius80 participantsStarted 2025-10-20
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years old.
✓. Women suffering from VVC or BV at the time of inclusion:
✓. For VVC: Subject with at least itching score \> 2 and crumbly white discharge.
✓. For BV: Subject with at least 3 out of 4 Amsel criteria positive, with at least presence of clue cells (\>20%).
✓. Subject having given freely and expressly her informed consent.
✓. Subject using a contraceptive regimen recognized as effective (pill, implant, Intra Uterine Device (IUD), condoms) since at least 12 weeks before inclusion visit and during the whole study.
✓. Subject cooperative and aware of the device's modalities of use and the necessity and duration of the follow-up visits so that perfect adhesion to the protocol can be expected
Exclusion criteria
✕. Pregnant or nursing woman or planning a pregnancy during the study.
✕. Subject suspected to be non-compliant according to the investigator's judgment.
What they're measuring
1
The effectiveness of Multi-Gyn FemiTotal for the treatment of Bacterial Vaginosis (BV) and relief of VulvoVaginal candidiasis symptoms will be evaluated by the investigator and questionnaires.