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Completed

NCT Number: NCT03761628

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

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).

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Key information

Conditions

Vulvovaginal Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hoftekliniken, Helsingborg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Any medical condition that in the Investigator's judgments would make the patient unsuitable for inclusion

Treatment and study plan

pHyph generation I

Device

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

Other names: Gedea pessary

Primary outcomes

  1. Clinical Cure Rate

    Time frame: Day 7

    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)
    • = mild (slight)
    • = moderate (definitely present)
    • = severe (marked, intense)

Secondary outcomes

  1. Proportion of Patients Having a Reduction in CVVS Score

    Time frame: Day 7 compared to Day 0

    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)
    • = mild (slight)
    • = moderate (definitely present)
    • = severe (marked, intense)

  2. Usability, Measured by Patient Questionnaire

    Time frame: Day 7

    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?

  3. Proportion of Patients Having a Recurrence

    Time frame: Up to day 35

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

Sponsors and collaborators

Lead sponsor

Gedea Biotech AB

Industry

Registry information

Official study title

An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Vulvovaginal Candidiasis

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Dec 3, 2018
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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