Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis

Not Applicable

Completed

Brief Summary: This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with vulvovaginal candidias (VVC). On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to VVC signs and symptoms and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing VVC symptoms, usability, and adverse events (AEs).

Recruitment & Eligibility

Inclusion Criteria

Adult, post-menarchal, pre-menopausal women aged 18 years or older
Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:
1. At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation.
2. Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.
Having decisional capacity and providing written informed consent
Negative urine pregnancy test at screening
Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period
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 VVC (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 the past 14 days
Patients who are currently receiving antifungal therapy unrelated to VVC or has taken antifungal therapy within the past 14 days
Patients who have used pH-modifying vaginal products within the last 14 days
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 judgments would make the patient unsuitable for inclusion

Primary Outcome Measures

Name	Time	Method
Clinical Cure Rate	Day 7	Clinical cure was defined as the absence of signs and symptoms of vulvovaginal candidiasis (VVC) in terms of having a composite vulvovaginal signs-and-symptoms (CVVS) score equal to or below 3. * Each of the following 6 vulvovaginal signs and symptoms were individually scored using the scoring scale below and then added together to determine the CVVS score. * Vulvovaginal signs: erythema, edema, or excoriation * Vulvovaginal symptoms: itching, burning, or irritation * Scoring Scale: each score should be objectively defined. 0 = none (absent) 1. = mild (slight) 2. = moderate (definitely present) 3. = severe (marked, intense)

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Having a Reduction in CVVS Score	Day 7 compared to Day 0	Defined as the absence of signs and symptoms of vulvovaginal candidiasis (VVC) in terms of having a composite vulvovaginal signs-and-symptoms (CVVS) score equal to or below 3. - Each of the following 6 vulvovaginal signs and symptoms were individually scored using the scoring scale below and then added together to determine the CVVS score. * Vulvovaginal signs: erythema, edema, or excoriation * Vulvovaginal symptoms: itching, burning, or irritation -Scoring Scale: each score should be objectively defined: 0 = none (absent) 1. = mild (slight) 2. = moderate (definitely present) 3. = severe (marked, intense)
Usability, Measured by Patient Questionnaire	Day 7	General assessment of the treatment on a integer scale that ranges from 1 to 10. The lower end of the scale is indicated with the term "Not satisfied" and the higher end with the term "Very satisfied". Question asked: How do you generally regard the treatment?
Proportion of Patients Having a Recurrence	Up to day 35	Proportion of patients answering \[Yes\] to the question "Have the symptoms recurred?"