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

Gedea Biotech AB26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Having decisional capacity and providing written informed consent. 2. Adult, post-menarchal, pre-menopausal women, aged 18 years or older 3. 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. 4. Negative urine pregnancy test at Screening. 5. Refrain from using any intravaginal products (i.e. contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) until Day 14. 6. Refrain from sexual intercourse or use a condom until Day 7. 7. Signed informed consent and willing and able to comply with all study requirements. Exclusion Criteria: 1. 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. 2. Patients who are pregnant or breastfeeding. 3. Patients who were treated for VVC within 14 days prior to Screening. 4. Patients who are currently receiving anti-fungal therapy unrelated to VVC or has taken anti-fungal therapy within 14 days prior to Screening. 5. Patients who have received an investigational drug in a clinical investigation within 30 days prior to Screening. 6. Known/previous allergy or hypersensitivity to any product constituent or fluconazole. 7. Any medical condition that in the Investigator's judgements would make the patient unsuitable for inclusion. 8. More than 3 previous VVC infections during the last 12 months.

Locations (4)

Carlanderska

Gothenburg, Sweden

KS Huddinge

Stockholm, Sweden

Danderyds sjukhus

Stockholm, Sweden

CTC MTC

Uppsala, Sweden

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes