| Eligibility |
Inclusion Criteria:
To be eligible, each patient must satisfy the following criteria:
1. Is a non-menopausal woman aged 18 to 45 years,
2. Suffering from a vulvovaginal candidiasis (according to clinical examination),
3. Who was being prescribed standard antifungal therapy for Vulvovaginal Candidiasis,
4. Has regular menstrual cycles (21-35 days) or no menstruation due to continuous use of
contraception,
5. Is able to understand the study related information and to give a written informed
consent,
6. Has signed the informed consent form before beginning any study procedure,
7. Agrees not to use other vaginal products than those planned in the study protocol,
during participation in the study,
8. Agrees not to use a diaphragm, spermicide or latex condoms, contraceptive creams and
spermicide ovules during participation in the study,
9. Uses an effective method of contraception (contraceptive steroid [oral, patch,
injection, implant], intrauterine device, vasectomized partner, history of permanent
sterilization such as tubal ligation, hysterectomy, etc.) or abstinence,
10. Has no condition that may interfere with the study assessments
11. Is affiliated to a health social security system,
12. Is able to comply with protocol requirements and respect the conditions of the study,
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.
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