Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKaro Pharma AB
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old.
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%).
Thin, white, yellow, homogeneous discharge,
Disqualifiers
Pregnant or nursing woman or planning a pregnancy during the study.
Subject suspected to be non-compliant according to the investigator's judgment.
Subject enrolled in another clinical trial during the study period on the vaginal area.
Subject having a known allergy or hypersensitivity to one of the components of the investigational device.
Trial design
Design model
Single group
Treatments tested in this trial
Multi-Gyn FemiTotal
Devicevaginal gel
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Study productExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Cured rated of subjects with BV will be evaluated based on Amsel criteria. Subjects with VVC will be evaluated based on improvement of the itch.
Time frame
21 daysSecondary outcomes
1
The prevention of BV and VVC re-occurrence will be evaluated by the doctor, 4 months after using the product.
Percentage of subjects without relapse of BV or VVC, 4 months after treatment initiation.
Time frame
4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov