Status:
COMPLETED
Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis
Lead Sponsor:
Gedea Biotech AB
Conditions:
Vulvovaginal Candidiasis
Eligibility:
FEMALE
18+ years
Phase:
NA
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, patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03761628
Start Date
January 7 2019
End Date
January 15 2020
Last Update
July 25 2025
Active Locations (2)
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1
Hoftekliniken
Helsingborg, Sweden
2
Annerokliniken
Hofterup, Sweden