Trial Outcomes & Findings for Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis (NCT NCT05507333)

NCT ID: NCT05507333

Last Updated: 2025-10-06

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, 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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: Day 7-14
• Results posted on: 2025-10-06

Participant Flow

Participant milestones

Measure	Gedea Pessary Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Overall Study STARTED	26
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Gedea Pessary Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Overall Study Protocol Violation	1

Baseline Characteristics

Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis

Baseline characteristics by cohort

Measure	Gedea Pessary n=26 Participants Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33.1 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized African descent	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	3 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	22 Participants n=5 Participants
Race/Ethnicity, Customized Mixed/Multi-racial	0 Participants n=5 Participants
Race/Ethnicity, Customized Other, Central American	1 Participants n=5 Participants
Region of Enrollment Sweden	26 participants n=5 Participants
Childbearing potential No	0 Participants n=5 Participants
Childbearing potential Yes	26 Participants n=5 Participants
Number of vulvovaginal candidiasis infections during the last 12 months 0	1 participants n=5 Participants
Number of vulvovaginal candidiasis infections during the last 12 months 1	12 participants n=5 Participants
Number of vulvovaginal candidiasis infections during the last 12 months 2	7 participants n=5 Participants
Number of vulvovaginal candidiasis infections during the last 12 months 3	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 7-14

Population: Full Analysis Set

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)

Outcome measures

Measure	Gedea Pessary n=26 Participants Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Clinical Cure Rate at Day 7-14 Clinical cure - No	10 Participants
Clinical Cure Rate at Day 7-14 Clinical cure - Yes	16 Participants

SECONDARY outcome

Timeframe: Day 25

Population: 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.

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.

Outcome measures

Measure	Gedea Pessary n=13 Participants Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Continued Clinical Response to Treatment at Day 25 Continued clinical response to treatment at Day 25 - Yes	11 Participants
Continued Clinical Response to Treatment at Day 25 Continued clinical response to treatment at Day 25 - No	2 Participants

SECONDARY outcome

Timeframe: Day 7-14

Population: Full Analysis Set

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).

Outcome measures

Measure	Gedea Pessary n=26 Participants Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Combined Clinical and Mycological Cure at Day 7-14 Clinical cure and mycological cure - No	16 Participants
Combined Clinical and Mycological Cure at Day 7-14 Clinical cure and mycological cure - Yes	10 Participants

SECONDARY outcome

Timeframe: Day 7-14

Population: Full Analysis Set

Defined as the proportion of patients having a mycological cure as assessed by vaginal culture at Day 7-14.

Outcome measures

Measure	Gedea Pessary n=26 Participants Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Mycological Cure at Day 7-14 Mycological cure - No	12 Participants
Mycological Cure at Day 7-14 Mycological cure - Yes	14 Participants

SECONDARY outcome

Timeframe: Day 25

Population: 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

Defined as the proportion of patients achieving mycological cure as assessed by vaginal culture at Day 25.

Outcome measures

Measure	Gedea Pessary n=13 Participants Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Mycological Cure at Day 25 Mycological cure - No	3 Participants
Mycological Cure at Day 25 Mycological cure - Yes	10 Participants

SECONDARY outcome

Timeframe: Day 7-14

Population: Full Analysis Set

Proportion of patients having an absence of Candida hyphae in the wet smear at Day 7-14.

Outcome measures

Measure	Gedea Pessary n=26 Participants Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Absence of Candida Hyphae in the Wet Smear "Absence of Candida hyphae in the wet smear" - No	11 Participants
Absence of Candida Hyphae in the Wet Smear "Absence of Candida hyphae in the wet smear" - Yes	15 Participants

SECONDARY outcome

Timeframe: From Screening to Day 7-14

Population: Full Analysis Set

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)

Outcome measures

Measure	Gedea Pessary n=26 Participants Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 CVVS score - Screening	7.46 score on a scale (Total range 0-18) Standard Deviation 2.02
Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 CVVS score - Day 7-14	2.96 score on a scale (Total range 0-18) Standard Deviation 2.54

SECONDARY outcome

Timeframe: From Screening to Day 7-14

Population: Full Analysis Set

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)

Outcome measures

Measure	Gedea Pessary n=26 Participants Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 - Proportions Reduction in signs/symptoms -No	3 Participants
Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 - Proportions Reduction in signs/symptoms -Yes	23 Participants

SECONDARY outcome

Timeframe: Day 1-7, Day 11, Day 14, Day 25

Population: Full Analysis Set

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.

Outcome measures

Measure	Gedea Pessary n=26 Participants Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 0 (post-treatment)	6 Participants
Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 1	14 Participants
Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 2	15 Participants
Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 3	17 Participants
Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 4	16 Participants
Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 5	21 Participants
Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 6	22 Participants
Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 7	22 Participants
Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 11	16 Participants
Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 14	9 Participants
Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 25	20 Participants

SECONDARY outcome

Timeframe: Day 1-7, Day 11, Day 14, Day 25

Population: Full Analysis Set

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.

Outcome measures

Measure	Gedea Pessary n=26 Participants Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 0 (post-treatment)	-0.200 units on a scale Standard Deviation 1.28
Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 1	-0.560 units on a scale Standard Deviation 1.92
Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 2	-1.24 units on a scale Standard Deviation 1.94
Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 3	-1.40 units on a scale Standard Deviation 2.31
Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 4	-1.50 units on a scale Standard Deviation 2.45
Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 5	-2.48 units on a scale Standard Deviation 1.90
Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 6	-2.75 units on a scale Standard Deviation 1.96
Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 7	-3.00 units on a scale Standard Deviation 2.19
Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 11	-2.63 units on a scale Standard Deviation 2.36
Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 14	-2.70 units on a scale Standard Deviation 2.16
Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening Day 25	-3.77 units on a scale Standard Deviation 2.54

SECONDARY outcome

Timeframe: Day 6

Population: Full Analysis Set (26 patients, 25 patients responded to the question)

Response to the question "is the vaginal pessary easy to use?"

Outcome measures

Measure	Gedea Pessary n=25 Participants Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Usability, Measured by Patient Questionnaire on Day 6. No	3 Participants
Usability, Measured by Patient Questionnaire on Day 6. Yes	22 Participants

Adverse Events

Gedea Pessary

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Gedea Pessary n=26 participants at risk Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days
Reproductive system and breast disorders Dysmenorrhoea	3.8% 1/26 • Number of events 1 • Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)
Reproductive system and breast disorders Vulvovaginal burning sensation	7.7% 2/26 • Number of events 2 • Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)
Reproductive system and breast disorders Vulvovaginal discomfort	11.5% 3/26 • Number of events 3 • Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)
Reproductive system and breast disorders Vulvovaginal pruritus	11.5% 3/26 • Number of events 3 • Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)
Infections and infestations Bacterial vaginosis	3.8% 1/26 • Number of events 1 • Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)
Infections and infestations Nasopharyngitis	11.5% 3/26 • Number of events 3 • Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)
Gastrointestinal disorders Abdominal pain	3.8% 1/26 • Number of events 1 • Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)
Gastrointestinal disorders Anal pruritus	3.8% 1/26 • Number of events 1 • Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)
Gastrointestinal disorders Diarrhoea	3.8% 1/26 • Number of events 1 • Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)
Skin and subcutaneous tissue disorders Vulvovaginal pruritus	7.7% 2/26 • Number of events 2 • Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)
Nervous system disorders Syncope	3.8% 1/26 • Number of events 1 • Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)

Additional Information

Annette Säfholm, CEO

Gedea Biotech AB

Phone: 0046 708 91 86 81

Email: annette.safholm@gedeabiotech.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place