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

Launched by KARO PHARMA AB · Sep 22, 2022

Keywords

ClinConnect Summary

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Gender

FEMALE

Eligibility criteria

• 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