Vulvovaginal CandidiasisEpHectNCT05507333
Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis
A study testing pHyph generation II in people with Vulvovaginal Candidiasis, run by Gedea Biotech AB at 4 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- pHyph generation II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesSweden
- Study dates
- 16 Mar 2023to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having decisional capacity and providing written informed consent.
- Adult, post-menarchal, pre-menopausal women, aged 18 years or older
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
- Patients who are pregnant or breastfeeding.
- Patients who were treated for VVC within 14 days prior to Screening.
- Patients who are currently receiving anti-fungal therapy unrelated to VVC or has taken anti-fungal therapy within 14 days prior to Screening.
- 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 judgements would make the patient unsuitable for inclusion.
- More than 3 previous VVC infections during the last 12 months.
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Carlanderska
Gothenburg, 405 45
KS Huddinge
Stockholm, 141 86
Danderyds sjukhus
Stockholm, 182 88
CTC MTC
Uppsala, 75237
About this study
Official title: An Open Labelled Study to Evaluate Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis
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™).
- Conditions
- Vulvovaginal Candidiasis
- Being tested
- pHyph generation II
- Keywords
- Vaginal Yeast Infection, Candidiasis, vulvovaginal, Genital diseases, female, Vaginitis, Vulvovaginitis, Vaginal diseases
- Medical subject headings
- Candidiasis, Vulvovaginal, Genital Diseases, Female, Vaginitis, Vulvovaginitis, Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pHyph generation IIDevice
Also called Gedea pessary
Daily administration of the Gedea pessary during 6 days
| Study group | Role | What they receive |
|---|---|---|
| Gedea pessary | Other | Gedea pessary administration Receives: Device: pHyph generation II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 7-14
Secondary outcomes (10)
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.
Measured: Day 25
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
- 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)
Measured: 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.
- 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)
Measured: 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.
Measured: 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.
Measured: 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?"
Measured: Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start16 Mar 2023
- Primary completion22 Feb 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gedea Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helena Kopp-Kallner, MD PhD, Principal investigator, Obstetrics & Gynecology, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507333
- Sponsor's protocol ID
- CL4
- Acronym
- EpHect
- Status last verified
- Sep 2025
- First submitted
- 24 May 2022
- Last updated
- 6 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Labelled Study to Evaluate Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT05507333
- Acronym / sponsor ID
- EpHect / CL4
- Conditions
- Vulvovaginal Candidiasis
- Keywords
- Vaginal Yeast Infection, Candidiasis, vulvovaginal, Genital diseases, female, Vaginitis, Vulvovaginitis, Vaginal diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Gedea Biotech ABIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Posted 6 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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™).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gedea pessary | Other | Device: pHyph generation IIGedea pessary administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- Patients who are pregnant or breastfeeding.
- Patients who were treated for VVC within 14 days prior to Screening.
- Patients who are currently receiving anti-fungal therapy unrelated to VVC or has taken anti-fungal therapy within 14 days prior to Screening.
- Patients who have received an investigational drug in a clinical investigation within 30 days prior to Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pHyph generation IIAlso: Gedea pessaryDaily administration of the Gedea pessary during 6 days | Device | Gedea pessary |
Primary outcome
Clinical Cure Rate at Day 7-14
Time frame: 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)
10 secondary outcomes
Continued Clinical Response to Treatment at Day 25
Time frame: Day 25
Combined Clinical and Mycological Cure at Day 7-14
Time frame: Day 7-14
Mycological Cure at Day 7-14
Time frame: Day 7-14
Mycological Cure at Day 25
Time frame: Day 25
Absence of Candida Hyphae in the Wet Smear
Time frame: Day 7-14
Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14
Time frame: From Screening to Day 7-14
Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 - Proportions
Time frame: 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
Time frame: 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
Time frame: Day 1-7, Day 11, Day 14, Day 25
Usability, Measured by Patient Questionnaire on Day 6.
Time frame: Day 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Kopp-Kallner, MD PhD principal investigator
Obstetrics & Gynecology, Danderyd Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pHyph generation II in people with Vulvovaginal Candidiasis, run by Gedea Biotech AB at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure Rate at Day 7-14 (time frame: Day 7-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.