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

NCT05507333 | Completed Results

• 1 other identifier: CL4
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 4

Brief 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. 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

Keywords

Vaginal Yeast Infection; Candidiasis, vulvovaginal; Genital diseases, female; Vaginitis; Vulvovaginitis; Vaginal diseases

Outcome Measures

Primary Outcomes (1)

• 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)

  Day 7-14

Secondary Outcomes (10)

• Continued Clinical Response to Treatment at Day 25

  Day 25

• Combined Clinical and Mycological Cure at Day 7-14

  Day 7-14

• Mycological Cure at Day 7-14

  Day 7-14

• Mycological Cure at Day 25

  Day 25

• Absence of Candida Hyphae in the Wet Smear

  Day 7-14

Study Arms (1)

Gedea pessary

OTHER

Gedea pessary administration

Device: pHyph generation II

Interventions

pHyph generation II DEVICE

Daily administration of the Gedea pessary during 6 days

Also known as: Gedea pessary

Gedea pessary

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• More than 3 previous VVC infections during the last 12 months.

Sponsors & Collaborators

• Gedea Biotech AB: lead

Study Sites (4)

Carlanderska

Gothenburg, 405 45, Sweden

Location

KS Huddinge

Stockholm, 141 86, Sweden

Location

Danderyds sjukhus

Stockholm, 182 88, Sweden

Location

CTC MTC

Uppsala, 75237, Sweden

Location

Related Links

• Sponsor webpage

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Genital Diseases, Female; Vaginitis; Vulvovaginitis; Vaginal Diseases

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Results Point of Contact

• Title: Annette Säfholm, CEO
• Organization: Gedea Biotech AB

annette.safholm@gedeabiotech.com

0046 708 91 86 81

Study Officials

• Helena Kopp-Kallner, MD PhD

  Obstetrics & Gynecology, Danderyd Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: August 18, 2022
• Study Start: March 16, 2023
• Primary Completion: February 22, 2024
• Study Completion: March 5, 2024
• Last Updated: October 6, 2025
• Results First Posted: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)