Trial Outcomes & Findings for Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis (NCT NCT03761628)

Results Overview

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. * 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. * Vulvovaginal signs: erythema, edema, or excoriation * Vulvovaginal symptoms: itching, burning, or irritation * Scoring Scale: each score should be objectively defined. 0 = none (absent) 1. = mild (slight) 2. = moderate (definitely present) 3. = severe (marked, intense)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Day 7

Results posted on

2025-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	23
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	1
Overall Study Pregnancy	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	pHyph, Gedea Pessary n=23 Participants 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
Age, Categorical <=18 years	0 Participants n=23 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=23 Participants
Age, Categorical >=65 years	0 Participants n=23 Participants
Age, Continuous	29.9 years STANDARD_DEVIATION 8.0 • n=23 Participants
Sex: Female, Male Female	23 Participants n=23 Participants
Sex: Female, Male Male	0 Participants n=23 Participants
Region of Enrollment Sweden	23 participants n=23 Participants
Experience of any vaginal candida infection during the last 12 months Yes	22 Participants n=23 Participants
Experience of any vaginal candida infection during the last 12 months No	1 Participants n=23 Participants

PRIMARY outcome

Timeframe: Day 7

Population: The Full analysis set population contained 23 patients. One patient was not included in this analysis due to missing clinical cure data (CVVS score).

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. * 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. * Vulvovaginal signs: erythema, edema, or excoriation * Vulvovaginal symptoms: itching, burning, or irritation * Scoring Scale: each score should be objectively defined. 0 = none (absent) 1. = mild (slight) 2. = moderate (definitely present) 3. = severe (marked, intense)

Outcome measures

Outcome measures
Measure	pHyph, Gedea Pessary n=22 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
Clinical Cure Rate	9 Participants

SECONDARY outcome

Timeframe: Day 7 compared to Day 0

Population: The Full analysis set population contained 23 patients. One patient was not included in this analysis due to missing clinical cure data (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. * Vulvovaginal signs: erythema, edema, or excoriation * Vulvovaginal symptoms: itching, burning, or irritation -Scoring Scale: each score should be objectively defined: 0 = none (absent) 1. = mild (slight) 2. = moderate (definitely present) 3. = severe (marked, intense)

Outcome measures

Outcome measures
Measure	pHyph, Gedea Pessary n=22 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
Proportion of Patients Having a Reduction in CVVS Score	16 Participants

SECONDARY outcome

Timeframe: Day 7

Population: The Full analysis set population contained 23 patients. One patient was not included in this analysis due to missing clinical cure data (CVVS score).

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?

Outcome measures

Outcome measures
Measure	pHyph, Gedea Pessary n=22 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
Usability, Measured by Patient Questionnaire	6.4 Integer scale (1-10) Standard Deviation 2.2

SECONDARY outcome

Timeframe: Up to day 35

Population: 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.

Proportion of patients answering \[Yes\] to the question "Have the symptoms recurred?"

Outcome measures

Outcome measures
Measure	pHyph, Gedea Pessary n=8 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
Proportion of Patients Having a Recurrence Day 14	1 Participants
Proportion of Patients Having a Recurrence Day 35	0 Participants

Adverse Events

pHyph, Gedea Pessary

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	pHyph, Gedea Pessary n=23 participants at risk 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
Nervous system disorders Headache	21.7% 5/23 • Number of events 6 • Up to day 42
Reproductive system and breast disorders Dysmenorrhoea	17.4% 4/23 • Number of events 5 • Up to day 42
Gastrointestinal disorders Abdominal pain upper	8.7% 2/23 • Number of events 2 • Up to day 42
Infections and infestations Nasopharyngitis	17.4% 4/23 • Number of events 4 • Up to day 42

Additional Information

Annette Säfholm, CEO

Gedea Biotech AB

Phone: 0046 708 91 86 81

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place