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

NCT07234786 | Recruiting

• 1 other identifier: 24-1774-U5 / 24INSE105
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bacterial Vaginosis; Vaginal Candidiasis

Outcome Measures

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.

  21 days

Secondary Outcomes (1)

• The prevention of BV and VVC re-occurrence will be evaluated by the doctor, 4 months after using the product.

  4 months

Study Arms (1)

Study product

EXPERIMENTAL

Multi-Gyn Femitotal vaginal gel

Device: Multi-Gyn FemiTotal

Interventions

Multi-Gyn FemiTotal DEVICE

vaginal gel

Study product

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).
• 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 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

You may not qualify 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 gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis).
• Subject with current genital malignancies.
• 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

Sponsors & Collaborators

• Karo Pharma AB: lead

Study Sites (1)

Dr Farah Bolaky

Quatre Bornes, Mauritius

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial; Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Candidiasis; Mycoses; Vulvovaginitis; Vulvitis; Vulvar Diseases

Central Study Contacts

Diana Zeneli, MD

CONTACT

0031614706949; diana.zeneli@karo.com

Johan Ohlson

CONTACT

johan.ohlson@karo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Vaginal gel

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: November 18, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)