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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
A vaginal tablet for the treatment of VVC to be administered every 48 hours
Hoftekliniken
Helsingborg, Sweden
Annerokliniken
Hofterup, Sweden
Clinical Cure Rate
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)
Time frame: Day 7
Proportion of Patients Having a Reduction in CVVS Score
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)
Time frame: Day 7 compared to Day 0
Usability, Measured by Patient Questionnaire
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?
Time frame: Day 7
Proportion of Patients Having a Recurrence
Proportion of patients answering \[Yes\] to the question "Have the symptoms recurred?"
Time frame: Up to day 35
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