An interventional study of pHyph generation II in Vulvovaginal Candidiasis, sponsored by Gedea Biotech AB. Completed at 4 sites in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Gedea Biotech AB · Not applicable, Interventional, and Treatment
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™).
109 studies on the registry are indexed under Candidiasis, Vulvovaginal; 14 are open to participants now.
This study's enrollment of 26 is below the median of 126 across 91 interventional studies indexed under Candidiasis, Vulvovaginal.
Browse Candidiasis, Vulvovaginal studies →Gedea Biotech AB is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of VVC, defined as:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gedea pessary administration
Device: pHyph generation II
Daily administration of the Gedea pessary during 6 days
Also known as: Gedea pessary
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
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
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
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
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
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
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
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
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
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
Usability, Measured by Patient Questionnaire on Day 6.
Response to the question "is the vaginal pessary easy to use?"
Time frame: Day 6
| Milestone | Gedea Pessary |
|---|---|
| Started | 26 |
| Completed | 25 |
| Not completed | 1 |
| Withdrew: Protocol violation | 1 |
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)
| Participants | Gedea Pessary |
|---|---|
| Clinical cure - No | 10 |
| Clinical cure - Yes | 16 |
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.
| Participants | Gedea Pessary |
|---|---|
| Continued clinical response to treatment at Day 25 - Yes | 11 |
| Continued clinical response to treatment at Day 25 - No | 2 |
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).
| Participants | Gedea Pessary |
|---|---|
| Clinical cure and mycological cure - No | 16 |
| Clinical cure and mycological cure - Yes | 10 |
Defined as the proportion of patients having a mycological cure as assessed by vaginal culture at Day 7-14.
| Participants | Gedea Pessary |
|---|---|
| Mycological cure - No | 12 |
| Mycological cure - Yes | 14 |
Defined as the proportion of patients achieving mycological cure as assessed by vaginal culture at Day 25.
| Participants | Gedea Pessary |
|---|---|
| Mycological cure - No | 3 |
| Mycological cure - Yes | 10 |
Proportion of patients having an absence of Candida hyphae in the wet smear at Day 7-14.
| Participants | Gedea Pessary |
|---|---|
| "Absence of Candida hyphae in the wet smear" - No | 11 |
| "Absence of Candida hyphae in the wet smear" - Yes | 15 |
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)
| score on a scale (Total range 0-18) | Gedea Pessary |
|---|---|
| CVVS score - Screening | 7.46 ± 2.02 |
| CVVS score - Day 7-14 | 2.96 ± 2.54 |
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)
| Participants | Gedea Pessary |
|---|---|
| Reduction in signs/symptoms -No | 3 |
| Reduction in signs/symptoms -Yes | 23 |
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.
| Participants | Gedea Pessary |
|---|---|
| Day 0 (post-treatment) | 6 |
| Day 1 | 14 |
| Day 2 | 15 |
| Day 3 | 17 |
| Day 4 | 16 |
| Day 5 | 21 |
| Day 6 | 22 |
| Day 7 | 22 |
| Day 11 | 16 |
| Day 14 | 9 |
| Day 25 | 20 |
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.
| units on a scale | Gedea Pessary |
|---|---|
| Day 0 (post-treatment) | -0.200 ± 1.28 |
| Day 1 | -0.560 ± 1.92 |
| Day 2 | -1.24 ± 1.94 |
| Day 3 | -1.40 ± 2.31 |
| Day 4 | -1.50 ± 2.45 |
| Day 5 | -2.48 ± 1.90 |
| Day 6 | -2.75 ± 1.96 |
| Day 7 | -3.00 ± 2.19 |
| Day 11 | -2.63 ± 2.36 |
| Day 14 | -2.70 ± 2.16 |
| Day 25 | -3.77 ± 2.54 |
Response to the question "is the vaginal pessary easy to use?"
| Participants | Gedea Pessary |
|---|---|
| No | 3 |
| Yes | 22 |
Collected over Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gedea Pessary | 0/26 (0%) | 0/26 (0%) | 16/26 (61.5%) |
| Event | Gedea Pessary |
|---|---|
| Vulvovaginal discomfortReproductive system and breast disorders | 3/26 |
| Vulvovaginal pruritusReproductive system and breast disorders | 3/26 |
| NasopharyngitisInfections and infestations | 3/26 |
| Vulvovaginal burning sensationReproductive system and breast disorders | 2/26 |
| Vulvovaginal pruritusSkin and subcutaneous tissue disorders | 2/26 |
| DysmenorrhoeaReproductive system and breast disorders | 1/26 |
| Bacterial vaginosisInfections and infestations | 1/26 |
| Abdominal painGastrointestinal disorders | 1/26 |
| Anal pruritusGastrointestinal disorders | 1/26 |
| DiarrhoeaGastrointestinal disorders | 1/26 |
| Age, Categorical(Participants) | Gedea Pessary |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 26 |
| >=65 years | 0 |
| Age, Continuous(years) | Gedea Pessary |
|---|---|
| Mean | 33.1 ± 9.4 |
| Sex: Female, Male(Participants) | Gedea Pessary |
|---|---|
| Female | 26 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Gedea Pessary |
|---|---|
| African descent | 0 |
| Asian or Pacific Islander | 3 |
| Caucasian | 22 |
| Mixed/Multi-racial | 0 |
| Other, Central American | 1 |
| Region of Enrollment(participants) | Gedea Pessary |
|---|---|
| Sweden | 26 |
| Childbearing potential(Participants) | Gedea Pessary |
|---|---|
| No | 0 |
| Yes | 26 |
| Number of vulvovaginal candidiasis infections during the last 12 months(participants) | Gedea Pessary |
|---|---|
| 0 | 1 |
| 1 | 12 |
| 2 | 7 |
| 3 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2023 to primary completion in Feb 2024, 11 months.
Results were first posted in Oct 2025, 1 year 7 months after primary completion.
Of 20 interventional studies with no phase under Candidiasis, Vulvovaginal, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's 11 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Gedea Biotech AB