Effect of Ultra-gyn® on Vulvovaginal Candidiasis

Exclusion Criteria

• •Patients meeting at least one of the following criteria cannot be included in the study:
• •Criteria related to a medical condition that would compromise patient safety or data fidelity:
• •1. Has had a sexually transmitted disease in the 21 days preceding screening or detected on this occasion,
• •2. Has a history of recurrent fungaemia,
• •3. Has a history of recurrent vulvovaginal candidiasis (defined as more than four episodes of vulvovaginal candidiasis in the previous year or two episodes in the last six months),
• •4. Has had pelvic surgery in the 3 months prior to screening,
• •5. Has had uterine or vaginal bleeding of unknown etiology,
• •6. Immunocompromised,
• •7. Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments,
• •8. Is pregnant (positive pregnancy test at screening), has given birth less than 2 months ago or is breastfeeding,
• •9. Has changed her method of contraception in the 2 months prior to screening,
• •Criteria related to contraindications to the product used within the study:
• •10. With a known allergy or presenting an hypersensitivity to one of the component of the study product,
• •11. Presenting a contraindication or special warning to the study product, according to the package leaflet, including concomitant use of antifungal therapy during Ultra-gyn application,
• •Criteria related to medications or situations that would interfere with or compromise data fidelity
• •12. Has taken systemic or intravaginal antibiotic or antifungal agents (other than those prescribed during the inclusion visit) in the 14 days preceding the screening visit,
• •13. Is not willing to stop taking probiotics dietary supplements and food products enriched with probiotics,
• •14. Is planning to change her usual habits (hygiene, dietary habits, tobacco and alcohol consumption, physical activity and sexual life) during the study,
• •15. Has participated in an interventional clinical study in the month prior to inclusion.