Actively Recruiting
Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections
Led by Karo Pharma AB · Updated on 2025-11-18
80
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Women currently suffering from vulvovaginal candidiasis (VVC) or bacterial vaginosis (BV)
- For VVC: Presence of itching with a score greater than 2 and crumbly white discharge
- For BV: At least 3 out of 4 Amsel criteria positive, including more than 20% clue cells
- Subject has given informed consent freely and expressly
- Using an effective contraceptive method (pill, implant, IUD, condoms) for at least 12 weeks before and during the study
- Able and willing to follow device use instructions and complete follow-up visits
You will not qualify if you...
- Pregnant or nursing women or those planning pregnancy during the study
- Subjects considered non-compliant by the investigator
- Participation in another vaginal area clinical trial during the study
- Known allergy or hypersensitivity to any component of the device
- Having sexually transmitted infections or other genital tract infections including aerobic vaginitis
- Current genital malignancies
- Received chemotherapy within 6 months before inclusion
- Received radiotherapy in the genito-urinary area within 12 months before inclusion
- Using treatment for vaginal conditions or infections at inclusion
- Using antibiotics within 14 days before inclusion
- Using vaginal douches and unwilling to stop during the study
- Having a pessary
- Any condition or medication judged by the investigator to pose undue risk to the subject
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dr Farah Bolaky
Quatre Bornes, Mauritius
Actively Recruiting
Research Team
D
Diana Zeneli, MD
CONTACT
J
Johan Ohlson
CONTACT
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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