Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections

Karo Pharma

Status: Enrolling

Conditions: Vaginal Candidiasis; Bacterial Vaginosis

Treatments: Device: Multi-Gyn FemiTotal

Study type: Interventional

Funder types: Industry

Identifiers

NCT07234786

24-1774-U5 / 24INSE105

Details and patient eligibility

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Age ≥ 18 years old.

2. Women suffering from VVC or BV at the time of inclusion:

3. For VVC: Subject with at least itching score > 2 and crumbly white discharge.

4. 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".

5. Subject having given freely and expressly her informed consent.

6. 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.

7. 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:

1. Pregnant or nursing woman or planning a pregnancy during the study.
2. Subject suspected to be non-compliant according to the investigator's judgment.
3. Subject enrolled in another clinical trial during the study period on the vaginal area.
4. Subject having a known allergy or hypersensitivity to one of the components of the investigational device.
5. 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 cervicitis, urethritis, salpingitis).
6. Subject with current genital malignancies.
7. Subject who had a chemotherapy treatment in the 6 months before inclusion.
8. Subject who had a radiotherapy treatment in the genito-urinary area in the 12 months before inclusion.
9. Subject using treatment for vaginal conditions, vaginal infections, or other intravaginal treatment at the time of inclusion.
10. Subject using antibiotics for any reason in the 14 days before inclusion.
11. Subject using vaginal douches and who do not wish to refrain using them during the clinical investigation.
12. Subject with a pessary.
13. Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Study product

Experimental group

Description:

Multi-Gyn Femitotal vaginal gel

Treatment:

Device: Multi-Gyn FemiTotal