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Prevention study for Bacterial Vaginosis
Official title Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections
ClinicalTrials.gov ID: NCT07234786
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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%). Amsel criteria used for the study:
- Thin, white, yellow, homogeneous discharge,
You likely can't join if
- 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.
- Subject suffering from a sexually transmitted gynaecological infection, genital tract infection or aerobic vaginitis (including clinical obvious...
- Subject with current genital malignancies.
See the full eligibility 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%). Amsel criteria used for the study:
- Thin, white, yellow, homogeneous discharge,
- Clue cells on wet mount microscopy \>20%,
- a vaginal fluid pH ≥4.5 when placing the discharge on litmus paper,
- Release fishy odor after adding 10% potassium hydroxide (KOH) solution to wet mount - also known as "whiff test".
- 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
- 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.
- Subject suffering from a sexually transmitted gynaecological infection, genital tract infection or aerobic vaginitis (including clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with...
- Subject with current genital malignancies.
- Subject who had a chemotherapy treatment in the 6 months before inclusion.
- Subject who had a radiotherapy treatment in the genito-urinary area in the 12 months before inclusion.
- Subject using treatment for vaginal conditions, vaginal infections, or other intravaginal treatment at the time of inclusion.
- Subject using antibiotics for any reason in the 14 days before inclusion.
- Subject using vaginal douches and who do not wish to refrain using them during the clinical investigation.
- Subject with a pessary.
- Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk
The study team makes the final eligibility decision.
Where it's taking place
- Quatre Bornes, Mauritius
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Quatre Bornes, Mauritius. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.