Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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™).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gedea pessary | Other | Gedea pessary administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pHyph generation II | Device | Daily administration of the Gedea pessary during 6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense) | Day 7-14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 25 |
| Combined Clinical and Mycological Cure at Day 7-14 |
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Helena Kopp-Kallner, MD PhD | Obstetrics & Gynecology, Danderyd Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carlanderska | Gothenburg | 405 45 | Sweden | |||
| KS Huddinge |
Not provided
| Label | URL |
|---|---|
| Sponsor webpage | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gedea Pessary | Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gedea Pessary | Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.
Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense) | Full Analysis Set | Posted | Count of Participants | Participants | Day 7-14 |
|
Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gedea Pessary | Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annette Säfholm, CEO | Gedea Biotech AB | 0046 708 91 86 81 | annette.safholm@gedeabiotech.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 4, 2023 | Jul 8, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2024 | Jul 8, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| D005831 | Genital Diseases, Female |
| D014627 | Vaginitis |
| D014848 | Vulvovaginitis |
| D014623 | Vaginal Diseases |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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). |
| Day 7-14 |
| 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. | Day 7-14 |
| Mycological Cure at Day 25 | Defined as the proportion of patients achieving mycological cure as assessed by vaginal culture at Day 25. | Day 25 |
| 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. | Day 7-14 |
| 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.
Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense) | From Screening to Day 7-14 |
| 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.
Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense) | From Screening to Day 7-14 |
| 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. | Day 1-7, Day 11, Day 14, Day 25 |
| 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. | Day 1-7, Day 11, Day 14, Day 25 |
| Usability, Measured by Patient Questionnaire on Day 6. | Response to the question "is the vaginal pessary easy to use?" | Day 6 |
| Stockholm |
| 141 86 |
| Sweden |
| Danderyds sjukhus | Stockholm | 182 88 | Sweden |
| CTC MTC | Uppsala | 75237 | Sweden |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Childbearing potential | Count of Participants | Participants |
|
| Number of vulvovaginal candidiasis infections during the last 12 months | Number | participants |
|
| OG000 |
| Gedea Pessary |
Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Day 25 |
|
|
|
|
| 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). | Full Analysis Set | Posted | Count of Participants | Participants | Day 7-14 |
|
|
|
|
| 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. | Full Analysis Set | Posted | Count of Participants | Participants | Day 7-14 |
|
|
|
|
| Secondary | Mycological Cure at Day 25 | Defined as the proportion of patients achieving mycological cure as assessed by vaginal culture at Day 25. | 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 | Posted | Count of Participants | Participants | Day 25 |
|
|
|
|
| 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. | Full Analysis Set | Posted | Count of Participants | Participants | Day 7-14 |
|
|
|
|
| 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.
Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense) | Full Analysis Set | Posted | Mean | Standard Deviation | score on a scale (Total range 0-18) | From Screening to Day 7-14 |
|
|
|
|
| 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.
Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense) | Full Analysis Set | Posted | Count of Participants | Participants | From Screening to Day 7-14 |
|
|
|
|
| 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. | Full Analysis Set | Posted | Count of Participants | Participants | Day 1-7, Day 11, Day 14, Day 25 |
|
|
|
| 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. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Day 1-7, Day 11, Day 14, Day 25 |
|
|
|
| Secondary | Usability, Measured by Patient Questionnaire on Day 6. | Response to the question "is the vaginal pessary easy to use?" | Full Analysis Set (26 patients, 25 patients responded to the question) | Posted | Count of Participants | Participants | Day 6 |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 16 |
| 26 |
| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Bacterial vaginosis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Anal pruritus | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vulvovaginal pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |
|
| Day 2 |
|
|
| Day 3 |
|
|
| Day 4 |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| Day 11 |
|
|
| Day 14 |
|
|
| Day 25 |
|
|
|
| Day 2 |
|
|
| Day 3 |
|
|
| Day 4 |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| Day 11 |
|
|
| Day 14 |
|
|
| Day 25 |
|
|