Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms

Karo Pharma

Status

Completed

Conditions

Vulvovaginal Candidiasis

Treatments

Device: Multi-Gyn FloraFem

Study type

Interventional

Funder types

Industry

Identifiers

NCT05552378

22E2054

Details and patient eligibility

About

Women diagnosed with Vulvovaginal Candidiasis by the health care professional will be enrolled in the study. All participants should fulfil inclusion and exclusion criteria.

The study product will be used for 5 days, once a day. The doctor will evaluate the patients before and at the end of the treatment.

Enrollment

40 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Women diagnosed with Vulvovaginal Candidiasis confirmed by:itching, and/or burning, irritation, edema, redness, crumbly white discharge
Aged >18 years
Signed written informed consent form
Willing to comply to the follow-up schedule
Subject affiliated to a health social security system.
Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end.

Exclusion criteria

Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, bacterial vaginosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)
Current genital malignancies
Chemotherapy for any reason in last 6 months
Radiotherapy in the genitourinary system in the last 12 months
Pregnancy or currently attempting to conceive
Lactation
Use of other treatment for vaginal conditions during the course of the clinical investigation
Known allergies to ingredients of the product
Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation