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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03761628
Recruitment Status : Completed
First Posted : December 3, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Gedea Biotech AB

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 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).

Condition or disease Intervention/treatment Phase
Vulvovaginal Candidiasis Device: pHyph, Gedea pessary Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Vulvovaginal Candidiasis
Actual Study Start Date : January 7, 2019
Actual Primary Completion Date : December 16, 2019
Actual Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: pHyph, Gedea Pessary
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.
Device: pHyph, Gedea pessary
pHyph is a vaginal tablet for the treatment of VVC




Primary Outcome Measures :
  1. Clinical cure rate [ Time Frame: Day 7 ]

    Defined as the absence of signs and symptoms of 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 will be 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)


Secondary Outcome Measures :
  1. Proportion of patients having a reduction in CVVS score [ Time Frame: Day 7 compared to Day 0 ]
    Scoring scale as above

  2. Usability, measured by patient questionnaire [ Time Frame: Day 7 ]
    General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased]

  3. Proportion of patients having a recurrence [ Time Frame: Up to day 42 ]
    Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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:

    1. 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.
    2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761628


Locations
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Sweden
Hoftekliniken
Helsingborg, Sweden
Annerokliniken
Hofterup, Sweden
Sponsors and Collaborators
Gedea Biotech AB
Investigators
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Principal Investigator: Monika Cardell, MD, PhD Kvinnokliniken, Region Skåne
Additional Information:
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Responsible Party: Gedea Biotech AB
ClinicalTrials.gov Identifier: NCT03761628    
Other Study ID Numbers: QRS-CL1-003
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gedea Biotech AB:
Vaginal Yeast Infection
Candidiasis, vulvovaginal
Genital diseases, female
Vaginitis
Vulvovaginitis
Vaginal diseases
Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Vulvitis
Vulvar Diseases