Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis

NCT03761628 | Completed Results

• 1 other identifier: QRS-CL1-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with vulvovaginal candidias (VVC). On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to VVC signs and symptoms and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing VVC symptoms, usability, and adverse events (AEs).

Conditions

Vulvovaginal Candidiasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical Cure Rate

  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)

  Day 7

Secondary Outcomes (3)

• Proportion of Patients Having a Reduction in CVVS Score

  Day 7 compared to Day 0

• Usability, Measured by Patient Questionnaire

  Day 7

• Proportion of Patients Having a Recurrence

  Up to day 35

Study Arms (1)

pHyph, Gedea Pessary

EXPERIMENTAL

Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.

Device: pHyph generation I

Interventions

pHyph generation I DEVICE

A vaginal tablet for the treatment of VVC to be administered every 48 hours

Also known as: Gedea pessary

pHyph, Gedea Pessary

Eligibility Criteria

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

You may qualify if:

• Adult, post-menarchal, pre-menopausal women aged 18 years or older
• Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:
• At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation.
• Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.
• Having decisional capacity and providing written informed consent
• Negative urine pregnancy test at screening
• Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period
• 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 VVC (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 the past 14 days
• Patients who are currently receiving antifungal therapy unrelated to VVC or has taken antifungal therapy within the past 14 days
• Patients who have used pH-modifying vaginal products within the last 14 days
• 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

Sponsors & Collaborators

• Gedea Biotech AB: lead

Study Sites (2)

Hoftekliniken

Helsingborg, Sweden

Location

Annerokliniken

Hofterup, 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

• Monika Cardell, MD, PhD

  Kvinnokliniken, Region Skåne

  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: November 29, 2018
• First Posted: December 3, 2018
• Study Start: January 7, 2019
• Primary Completion: December 16, 2019
• Study Completion: January 15, 2020
• Last Updated: July 25, 2025
• Results First Posted: July 25, 2025

Record last verified: 2025-07

Locations

SE (2)