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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pHyph, Gedea Pessary | Experimental | Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pHyph generation I | Device | A vaginal tablet for the treatment of VVC to be administered every 48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Monika Cardell, MD, PhD | Kvinnokliniken, Region Skåne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoftekliniken | Helsingborg | Sweden | ||||
| Annerokliniken |
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| Label | URL |
|---|---|
| Sponsor webpage | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | pHyph, Gedea Pessary | Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC. pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of VVC |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 24 participants were enrolled, whereof 23 participants received study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| 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 | 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.
| The Full analysis set population contained 23 patients. One patient was not included in this analysis due to missing clinical cure data (CVVS score). | Posted | Count of Participants | Participants | Day 7 |
|
Up to day 42
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | pHyph, Gedea Pessary | Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC. pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of VVC |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annette Säfholm, CEO | Gedea Biotech AB | 0046 708 91 86 81 | annette.safholm@gedeabiotech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2018 | Jul 8, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 14, 2020 | Jul 8, 2025 | SAP_001.pdf |
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| 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 |
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| 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? | Day 7 |
| Proportion of Patients Having a Recurrence | Proportion of patients answering [Yes] to the question "Have the symptoms recurred?" | Up to day 35 |
| Hofterup |
| Sweden |
| Lost to Follow-up |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Experience of any vaginal candida infection during the last 12 months | Count of Participants | Participants |
|
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.
pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of VVC
|
|
|
| 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.
| The Full analysis set population contained 23 patients. One patient was not included in this analysis due to missing clinical cure data (CVVS score). | Posted | Count of Participants | Participants | Day 7 compared to Day 0 |
|
|
|
|
| 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? | The Full analysis set population contained 23 patients. One patient was not included in this analysis due to missing clinical cure data (CVVS score). | Posted | Mean | Standard Deviation | Integer scale (1-10) | Day 7 |
|
|
|
| Secondary | Proportion of Patients Having a Recurrence | Proportion of patients answering [Yes] to the question "Have the symptoms recurred?" | 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. | Posted | Count of Participants | Participants | Up to day 35 |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 12 |
| 23 |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (22.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |
|
| Recurrence rate Day 35 |
| 0 |
| 2-Sided |
| 95 |
| 0 |
| 45.9 |
| Other |
Results are based on the exact binomial distribution (Clopper-Pearson). |