Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis

Study Overview
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Brief Summary
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This is a multi-centre, multi-national study to evaluate the clinical performance and safety of treatment with Gedea Pessary in adult women with confirmed VVC. The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms. A total of 26 patients are planned to be included in the study. On Day 0 (Screening, Visit 1), eligible patients will undergo a gynaecological examination, including collection of CVVS data, and vaginal samples. Patients will be provided with 6 doses of Gedea Pessary that will be self-administered as a daily treatment (Days 0 to 5). Patients will visit the clinic on Day 7 (+2 days, Visit 2) for gynaecological examinations, including collection of CVVS data for the assessment of clinical cure and reporting of AEs and concomitant medications. On Day 14 (±2 days, Visit 3), patients that did not have a clinical and mycological cure Day 7 will re-visit the clinic for additional gynaecological examinations, including collection of CVVS data for the assessment of clinical cure. Rescue treatment will be offered during visits 2 and 3, if necessary. Patients will have a final telephone follow-up on Day 25 (±3 days, Visit 4), for for reporting of AEs, concomitant medications and potential menstruation onset. Vaginal sampling for culture and sequencing, as well as vaginal pH measuremetnts will be performed at the clinic on Day 0, Day 7, and Day 14. On Day 25, patients will self-perform vaginal swabs at home for sequencing and vaginal culture. Patient questionnaires for assessing VVC symptoms, will be used during the treatment period (Days 0 to 5), 1 day after the treatment (Day 6) and on Days 11 and 25. Usability will be assessed on Day 7, also via the patient questionaire. The patient questionnaire will be based on an electronic patient reported outcomes (ePRO) system, i.e. a mobile application (ViedocMe™).

Official Title
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An Open Labelled Study to Evaluate Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis

Conditions
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Vulvovaginal Candidiasis

Intervention / Treatment
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* Device: Gedea pessary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having decisional capacity and providing written informed consent. Adult, post-menarchal, pre-menopausal women, aged 18 years or older Diagnosis of VVC, defined as: Having a white or creamy vaginal discharge At least 2 of the following signs and symptoms of VVC that are characterised as at least moderate: itching, burning, irritation, oedema, erythema, or excoriation. KOH or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts. Negative urine pregnancy test at Screening. Refrain from using any intravaginal products (i.e. contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) until Day 14. Refrain from sexual intercourse or use a condom until Day 7. Signed informed consent and willing and able to comply with all study requirements. Exclusion Criteria: Patients with known or apparent signs of other infectious causes of vaginal infection (BV, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at Screening. Patients who are pregnant or breastfeeding. Patients who were treated for VVC within 14 days prior to Screening. Patients who are currently receiving anti-fungal therapy unrelated to VVC or has taken anti-fungal therapy within 14 days prior to Screening. Patients who have received an investigational drug in a clinical investigation within 30 days prior to Screening. Known/previous allergy or hypersensitivity to any product constituent or fluconazole. Any medical condition that in the Investigator's judgements would make the patient unsuitable for inclusion. More than 3 previous VVC infections during the last 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Gedea pessary<br>Gedea pessary administration | Device: Gedea pessary<br>* Daily administration of the Gedea pessary during 6 days<br>* Other names: pHyph;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate on Day 7-14, defined as the percentage of patients clinically cured at Day 7-14. |  | Day 7-14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability, based on reported treatment-emergent adverse events (AEs) (safety endpoint). |  | Day 0-25 | 
| Proportion of patients having a continued clinical response to treatment at Day 25, defined as the proportion of patients clinically cured on Day 7-14 and thereafter responding no to the yes/no question, Have the symptoms recurred? |  | Day 25 | 
| Proportion of patients having a cure defined as clinical cure Day 7-14 according to primary endpoint and mycological cure (culture negative for growth of Candida species). |  | Day 7-14 | 
| Proportion of patients having a reduction in composite vulvovaginal signs and symptoms (CVVS) (CVVS) score on Day 7-14 compared to Day 0. |  | Day 7-14 | 
| Change in the composite vulvovaginal signs and symptoms (CVVS) score from Day 0 to Day 7-14 | A lower CVVS score means less vulvovaginal signs and symptoms | Day 7-14 | 
| Proportion of patients having a reduction in the sum of the 3 vulvovaginal symptoms scores (itching, burning, and irritation) on Days 1-7, Day 11, Day 14 and Day 25, compared to Day 0 | A lower CVVS score means less vulvovaginal signs and symptoms | Day 1-7, Day 11, Day 14, Day 25 | 
| Change in the sum of the 3 vulvovaginal symptoms scores (itching, burning, and irritation) on Days 1-7, Day 11, Day 14 and Day 25, compared to Day 0. |  | Day 1-7, Day 11, Day 14, Day 25 | 
| Proportion of patients having a mycological cure as assessed by vaginal culture on Day 7- 14 and Day 25. |  | Day 7-14 and 25 | 
| Proportion of patients having an absence of Candida hyphae in the wet smear on Day 7-14. |  | Day 7-14 | 
| Usability, measured by patient questionnaire, on Day 7. |  | Day 7 |