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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra-gyn® | Other | ovule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra-gyn® | Device | Ultra-gyn® ovule intravaginal application, every evening before bedtime for a 10 days period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of Ultra-gyn® in relieving the symptoms of Vulvovaginal Candidiasis | Change in vulvovaginal symptoms (5-point rating scale (ranging from 0 to 4, where 0=None and 4=Very severe) for vaginal itching, vaginal burning or soreness and vaginal discharge) | Day 0 to Day 30 (+/-5) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of Ultra-gyn® on Candida spp | Change in vaginal load of Candida spp (CFU Enumeration) | Day 0 and Day 30 (+/-5) |
| To assess the effect of Ultra-gyn® on vaginal microbiota | Analysis with shotgun metagenomic sequencing of change in taxonomic composition of the vaginal microbiota |
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Inclusion Criteria:
To be eligible, each patient must satisfy the following criteria:
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IR | Recruiting | Quatre Bornes | 60200 | Mauritius |
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| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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A Prospective, Single-center, Open-label, Post-market Clinical Follow-up Study
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| Day 0 and Day 30 (+/-5) |
| To assess the incidence of adverse effects | Number, nature and characteristics of any adverse reactions | Day 1 to Day 30 (+/-5) |
| To assess the incidence of device deficiencies | Number, nature and characteristics of any device deficiencies | Day 1 to Day 30 (+/-5) |
| D014848 |
| Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |