Status:
UNKNOWN
Effect of Ultra-gyn® on Vulvovaginal Candidiasis
Lead Sponsor:
Biocodex
Conditions:
Vulvovaginal Candidiasis, Genital
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The aim of this post-market clinical follow up study is to confirm the performance and the safety of Ultra-gyn® (when used in accordance with its approved labelling)
Eligibility Criteria
Inclusion
- To be eligible, each patient must satisfy the following criteria:
- Is a non-menopausal woman aged 18 to 45 years,
- Suffering from a vulvovaginal candidiasis (according to clinical examination),
- Who was being prescribed standard antifungal therapy for Vulvovaginal Candidiasis,
- Has regular menstrual cycles (21-35 days) or no menstruation due to continuous use of contraception,
- Is able to understand the study related information and to give a written informed consent,
- Has signed the informed consent form before beginning any study procedure,
- Agrees not to use other vaginal products than those planned in the study protocol, during participation in the study,
- Agrees not to use a diaphragm, spermicide or latex condoms, contraceptive creams and spermicide ovules during participation in the study,
- 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,
- Has no condition that may interfere with the study assessments
- Is affiliated to a health social security system,
- Is able to comply with protocol requirements and respect the conditions of the study,
Exclusion
- 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:
- Has had a sexually transmitted disease in the 21 days preceding screening or detected on this occasion,
- Has a history of recurrent fungaemia,
- 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),
- Has had pelvic surgery in the 3 months prior to screening,
- Has had uterine or vaginal bleeding of unknown etiology,
- Immunocompromised,
- Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments,
- Is pregnant (positive pregnancy test at screening), has given birth less than 2 months ago or is breastfeeding,
- Has changed her method of contraception in the 2 months prior to screening,
- Criteria related to contraindications to the product used within the study:
- With a known allergy or presenting an hypersensitivity to one of the component of the study product,
- 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
- 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,
- Is not willing to stop taking probiotics dietary supplements and food products enriched with probiotics,
- Is planning to change her usual habits (hygiene, dietary habits, tobacco and alcohol consumption, physical activity and sexual life) during the study,
- Has participated in an interventional clinical study in the month prior to inclusion.
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05273333
Start Date
February 23 2022
End Date
December 1 2022
Last Update
March 10 2022
Active Locations (1)
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1
IR
Quatre Bornes, Mauritius, 60200