Vulvovaginal Candidiasis
Conditions
Keywords
Vaginal Yeast Infection, Candidiasis, vulvovaginal, Genital diseases, female, Vaginitis, Vulvovaginitis, Vaginal diseases
Brief summary
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 vulvovaginal candidiasis (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 composite vulvovaginal signs-and-symptoms (CVVS) score 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 measurements 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 questionnaire. The patient questionnaire will be based on an electronic patient reported outcomes (ePRO) system, i.e. a mobile application (ViedocMe™).
Interventions
DEVICEpHyph generation II
Daily administration of the Gedea pessary during 6 days
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
1. Having decisional capacity and providing written informed consent. 2. Adult, post-menarchal, pre-menopausal women, aged 18 years or older 3. 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. 4. Negative urine pregnancy test at Screening. 5. Refrain from using any intravaginal products (i.e. contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) until Day 14. 6. Refrain from sexual intercourse or use a condom until Day 7. 7. Signed informed consent and willing and able to comply with all study requirements.
Exclusion criteria
1. 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. 2. Patients who are pregnant or breastfeeding. 3. Patients who were treated for VVC within 14 days prior to Screening. 4. Patients who are currently receiving anti-fungal therapy unrelated to VVC or has taken anti-fungal therapy within 14 days prior to Screening. 5. Patients who have received an investigational drug in a clinical investigation within 30 days prior to Screening. 6. Known/previous allergy or hypersensitivity to any product constituent or fluconazole. 7. Any medical condition that in the Investigator's judgements would make the patient unsuitable for inclusion. 8. More than 3 previous VVC infections during the last 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure Rate at Day 7-14 | Day 7-14 | 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, with no intercurrent events (concomitant anti-fungal therapy or other treatments related to VVC due to lack of clinical performance prior to CVVS evaluation for the primary endpoint definition, treatment discontinuation due to lack of clinical performance, or rescue medication prior to CVVS evaluation for the primary endpoint definition). Each of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. The CVVS score is the sum of the 6 individual scores. * Vulvovaginal signs: erythema, edema, or excoriation * Vulvovaginal symptoms: itching, burning, or irritation Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combined Clinical and Mycological Cure at Day 7-14 | Day 7-14 | The proportion of patients reporting clinical cure Day 7-14 according to the primary endpoint and mycological cure (culture negative for growth of Candida species). |
| Mycological Cure at Day 7-14 | Day 7-14 | Defined as the proportion of patients having a mycological cure as assessed by vaginal culture at Day 7-14. |
| Mycological Cure at Day 25 | Day 25 | Defined as the proportion of patients achieving mycological cure as assessed by vaginal culture at Day 25. |
| Absence of Candida Hyphae in the Wet Smear | Day 7-14 | Proportion of patients having an absence of Candida hyphae in the wet smear at Day 7-14. |
| Continued Clinical Response to Treatment at Day 25 | 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? via telephone on Day 25. |
| Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 - Proportions | From Screening to Day 7-14 | Proportion of patients having a reduction in composite vulvovaginal signs and symptoms (CVVS) score on Day 7-14 compared to screening. NB. If the patient used rescue medication between Day 7 and Day 14, Day 7 data was used. Each of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. The CVVS score is the sum of the 6 individual scores. * Vulvovaginal signs: erythema, edema, or excoriation * Vulvovaginal symptoms: itching, burning, or irritation Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense) |
| Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 1-7, Day 11, Day 14, Day 25 | The number of participants reported as Yes for having a reduction in CVVS score compared to screening is presented. Each of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. A lower CVVS score means fewer vulvovaginal symptoms. • Vulvovaginal symptoms: itching, burning, or irritation Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense). Please note that assessments at Day 0 refer to the evening assessment post-treatment. |
| Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | 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 screening. Vulvovaginal symptoms were individually scored using the scoring scale below. • Vulvovaginal symptoms: itching, burning, or irritation Scoring scale: each score was objectively defined as 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense). Please note that assessments at Day 0 refer to the evening assessment post-treatment. |
| Usability, Measured by Patient Questionnaire on Day 6. | Day 6 | Response to the question is the vaginal pessary easy to use? |
| Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 | From Screening to Day 7-14 | Each of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. The CVVS score is the sum of the 6 individual scores. A lower CVVS score means fewer vulvovaginal signs and symptoms. Change from the score at screening to the score at Day 7-14 is presented. * Vulvovaginal signs: erythema, edema, or excoriation (Investigator-assessed) * Vulvovaginal symptoms: itching, burning, or irritation (Patient-assessed) Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense) |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gedea Pessary Gedea pessary administration
Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Gedea Pessary |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 33.1 years STANDARD_DEVIATION 9.4 |
| Childbearing potential No | 0 Participants |
| Childbearing potential Yes | 26 Participants |
| Number of vulvovaginal candidiasis infections during the last 12 months 0 | 1 participants |
| Number of vulvovaginal candidiasis infections during the last 12 months 1 | 12 participants |
| Number of vulvovaginal candidiasis infections during the last 12 months 2 | 7 participants |
| Number of vulvovaginal candidiasis infections during the last 12 months 3 | 6 participants |
| Race/Ethnicity, Customized African descent | 0 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 22 Participants |
| Race/Ethnicity, Customized Mixed/Multi-racial | 0 Participants |
| Race/Ethnicity, Customized Other, Central American | 1 Participants |
| Region of Enrollment Sweden | 26 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 16 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Clinical Cure Rate at Day 7-14
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, with no intercurrent events (concomitant anti-fungal therapy or other treatments related to VVC due to lack of clinical performance prior to CVVS evaluation for the primary endpoint definition, treatment discontinuation due to lack of clinical performance, or rescue medication prior to CVVS evaluation for the primary endpoint definition). Each of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. The CVVS score is the sum of the 6 individual scores. * Vulvovaginal signs: erythema, edema, or excoriation * Vulvovaginal symptoms: itching, burning, or irritation Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense)
Time frame: Day 7-14
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gedea Pessary | Clinical Cure Rate at Day 7-14 | Clinical cure - No | 10 Participants |
| Gedea Pessary | Clinical Cure Rate at Day 7-14 | Clinical cure - Yes | 16 Participants |
Comparison: It was assumed that the true clinical cure rate was 54% in the treatment group, therefore a sample size of 24 patients was needed to obtain 80% power to show that the one-sided 95% CI for the clinical cure rate was above 30%. A sample size of 26 was used to account for patients with missing data.~Hypotheses for the primary endpoint:~Null hypothesis: Clinical cure rate is less than or equal to 30%.~Alternative hypothesis (one-sided): Clinical cure rate is above 30%95% CI: [0.4073, 0.7909]
Secondary
Absence of Candida Hyphae in the Wet Smear
Proportion of patients having an absence of Candida hyphae in the wet smear at Day 7-14.
Time frame: Day 7-14
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gedea Pessary | Absence of Candida Hyphae in the Wet Smear | Absence of Candida hyphae in the wet smear - No | 11 Participants |
| Gedea Pessary | Absence of Candida Hyphae in the Wet Smear | Absence of Candida hyphae in the wet smear - Yes | 15 Participants |
95% CI: [0.3719, 0.7603]
Secondary
Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14
Each of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. The CVVS score is the sum of the 6 individual scores. A lower CVVS score means fewer vulvovaginal signs and symptoms. Change from the score at screening to the score at Day 7-14 is presented. * Vulvovaginal signs: erythema, edema, or excoriation (Investigator-assessed) * Vulvovaginal symptoms: itching, burning, or irritation (Patient-assessed) Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense)
Time frame: From Screening to Day 7-14
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gedea Pessary | Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 | CVVS score - Screening | 7.46 score on a scale (Total range 0-18) | Standard Deviation 2.02 |
| Gedea Pessary | Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 | CVVS score - Day 7-14 | 2.96 score on a scale (Total range 0-18) | Standard Deviation 2.54 |
95% CI: [-5.77, -3.23]
Secondary
Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 - Proportions
Proportion of patients having a reduction in composite vulvovaginal signs and symptoms (CVVS) score on Day 7-14 compared to screening. NB. If the patient used rescue medication between Day 7 and Day 14, Day 7 data was used. Each of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. The CVVS score is the sum of the 6 individual scores. * Vulvovaginal signs: erythema, edema, or excoriation * Vulvovaginal symptoms: itching, burning, or irritation Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense)
Time frame: From Screening to Day 7-14
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gedea Pessary | Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 - Proportions | Reduction in signs/symptoms -Yes | 23 Participants |
| Gedea Pessary | Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 - Proportions | Reduction in signs/symptoms -No | 3 Participants |
95% CI: [0.6872, 0.9697]
Secondary
Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening
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 screening. Vulvovaginal symptoms were individually scored using the scoring scale below. • Vulvovaginal symptoms: itching, burning, or irritation Scoring scale: each score was objectively defined as 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense). Please note that assessments at Day 0 refer to the evening assessment post-treatment.
Time frame: Day 1-7, Day 11, Day 14, Day 25
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gedea Pessary | Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 1 | -0.560 units on a scale | Standard Deviation 1.92 |
| Gedea Pessary | Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 2 | -1.24 units on a scale | Standard Deviation 1.94 |
| Gedea Pessary | Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 11 | -2.63 units on a scale | Standard Deviation 2.36 |
| Gedea Pessary | Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 14 | -2.70 units on a scale | Standard Deviation 2.16 |
| Gedea Pessary | Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 25 | -3.77 units on a scale | Standard Deviation 2.54 |
| Gedea Pessary | Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 0 (post-treatment) | -0.200 units on a scale | Standard Deviation 1.28 |
| Gedea Pessary | Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 3 | -1.40 units on a scale | Standard Deviation 2.31 |
| Gedea Pessary | Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 4 | -1.50 units on a scale | Standard Deviation 2.45 |
| Gedea Pessary | Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 5 | -2.48 units on a scale | Standard Deviation 1.9 |
| Gedea Pessary | Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 6 | -2.75 units on a scale | Standard Deviation 1.96 |
| Gedea Pessary | Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 7 | -3.00 units on a scale | Standard Deviation 2.19 |
Secondary
Combined Clinical and Mycological Cure at Day 7-14
The proportion of patients reporting clinical cure Day 7-14 according to the primary endpoint and mycological cure (culture negative for growth of Candida species).
Time frame: Day 7-14
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gedea Pessary | Combined Clinical and Mycological Cure at Day 7-14 | Clinical cure and mycological cure - No | 16 Participants |
| Gedea Pessary | Combined Clinical and Mycological Cure at Day 7-14 | Clinical cure and mycological cure - Yes | 10 Participants |
95% CI: [0.2091, 0.5927]
Secondary
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? via telephone on Day 25.
Time frame: Day 25
Population: Day 25 Per Protocol Analysis Set - the subset of patients in the Full Analysis Set for whom no protocol deviation judged to impact the Day 25 analyses was reported or identified.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gedea Pessary | Continued Clinical Response to Treatment at Day 25 | Continued clinical response to treatment at Day 25 - Yes | 11 Participants |
| Gedea Pessary | Continued Clinical Response to Treatment at Day 25 | Continued clinical response to treatment at Day 25 - No | 2 Participants |
95% CI: [0.5366, 0.9729]
Secondary
Mycological Cure at Day 25
Defined as the proportion of patients achieving mycological cure as assessed by vaginal culture at Day 25.
Time frame: Day 25
Population: Day 25 Per Protocol Analysis Set - the subset of patients in the Full Analysis Set for whom no protocol deviation judged to impact the Day 25 analyses was reported or identified
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gedea Pessary | Mycological Cure at Day 25 | Mycological cure - No | 3 Participants |
| Gedea Pessary | Mycological Cure at Day 25 | Mycological cure - Yes | 10 Participants |
95% CI: [0.4598, 0.9384]
Secondary
Mycological Cure at Day 7-14
Defined as the proportion of patients having a mycological cure as assessed by vaginal culture at Day 7-14.
Time frame: Day 7-14
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gedea Pessary | Mycological Cure at Day 7-14 | Mycological cure - Yes | 14 Participants |
| Gedea Pessary | Mycological Cure at Day 7-14 | Mycological cure - No | 12 Participants |
95% CI: [0.3375, 0.7286]
Secondary
Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening
The number of participants reported as Yes for having a reduction in CVVS score compared to screening is presented. Each of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. A lower CVVS score means fewer vulvovaginal symptoms. • Vulvovaginal symptoms: itching, burning, or irritation Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense). Please note that assessments at Day 0 refer to the evening assessment post-treatment.
Time frame: Day 1-7, Day 11, Day 14, Day 25
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gedea Pessary | Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 0 (post-treatment) | 6 Participants |
| Gedea Pessary | Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 1 | 14 Participants |
| Gedea Pessary | Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 2 | 15 Participants |
| Gedea Pessary | Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 3 | 17 Participants |
| Gedea Pessary | Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 4 | 16 Participants |
| Gedea Pessary | Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 5 | 21 Participants |
| Gedea Pessary | Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 6 | 22 Participants |
| Gedea Pessary | Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 7 | 22 Participants |
| Gedea Pessary | Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 11 | 16 Participants |
| Gedea Pessary | Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 14 | 9 Participants |
| Gedea Pessary | Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening | Day 25 | 20 Participants |
Secondary
Usability, Measured by Patient Questionnaire on Day 6.
Response to the question is the vaginal pessary easy to use?
Time frame: Day 6
Population: Full Analysis Set (26 patients, 25 patients responded to the question)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gedea Pessary | Usability, Measured by Patient Questionnaire on Day 6. | No | 3 Participants |
| Gedea Pessary | Usability, Measured by Patient Questionnaire on Day 6. | Yes | 22 Participants |