Vulvovaginal Candidiasis
Conditions
Keywords
Vaginal Yeast Infection, Candidiasis, vulvovaginal, Genital diseases, female, Vaginitis, Vulvovaginitis, Vaginal diseases
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).
Interventions
DEVICEpHyph generation I
A vaginal tablet for the treatment of VVC to be administered every 48 hours
Sponsors
Gedea Biotech AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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? |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| pHyph, Gedea Pessary Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of vulvovaginal candidiasis (VVC).
pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of VVC | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | pHyph, Gedea Pessary | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 23 Participants | — |
| Age, Continuous | 29.9 years STANDARD_DEVIATION 8 | — |
| Experience of any vaginal candida infection during the last 12 months No | 1 Participants | — |
| Experience of any vaginal candida infection during the last 12 months Yes | 22 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Sweden | 23 participants | — |
| Sex: Female, Male Female | 23 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 12 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
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
Population: The Full analysis set population contained 23 patients. One patient was not included in this analysis due to missing clinical cure data (CVVS score).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| pHyph, Gedea Pessary | Clinical Cure Rate | 9 Participants |
Comparison: It was assumed that the true cure rate was equal to 70%, therefore 22 patients were needed to obtain 90% chance (90% power) to show that the one-sided 95% CI for the observed cure rate was above 40%.~Hypotheses for the primary clinical performance endpoint:~* Null hypothesis: Clinical cure rate is less than or equal to 40%.~* Alternative hypothesis (one-sided): Clinical cure rate is above 40%.
Secondary
Proportion of Patients Having a Recurrence
Proportion of patients answering \[Yes\] to the question Have the symptoms recurred?
Time frame: Up to day 35
Population: The Full analysis set population contained 23 patients.The sub-set of the Full analysis set including patients not receiving prolonged treatment contained 9 patients. Of these, 8 patients were included in this analysis of recurrence at Day 14 and 6 patients were included in the analysis of recurrence at Day 35.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| pHyph, Gedea Pessary | Proportion of Patients Having a Recurrence | Day 14 | 1 Participants |
| pHyph, Gedea Pessary | Proportion of Patients Having a Recurrence | Day 35 | 0 Participants |
95% CI: [0.3, 52.7]
95% CI: [0, 45.9]
Secondary
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
Population: The Full analysis set population contained 23 patients. One patient was not included in this analysis due to missing clinical cure data (CVVS score).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| pHyph, Gedea Pessary | Proportion of Patients Having a Reduction in CVVS Score | 16 Participants |
95% CI: [49.8, 89.3]
Secondary
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
Population: The Full analysis set population contained 23 patients. One patient was not included in this analysis due to missing clinical cure data (CVVS score).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| pHyph, Gedea Pessary | Usability, Measured by Patient Questionnaire | 6.4 Integer scale (1-10) | Standard Deviation 2.2 |