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

Primary Purpose

Vulvovaginal Candidiasis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
pHyph, Gedea pessary
Sponsored by
Gedea Biotech AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Candidiasis focused on measuring Vaginal Yeast Infection, Candidiasis, vulvovaginal, Genital diseases, female, Vaginitis, Vulvovaginitis, Vaginal diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hoftekliniken
  • Annerokliniken

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pHyph, Gedea Pessary

Arm Description

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

Outcomes

Primary Outcome Measures

Clinical cure rate
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) = mild (slight) = moderate (definitely present) = severe (marked, intense)

Secondary Outcome Measures

Proportion of patients having a reduction in CVVS score
Scoring scale as above
Usability, measured by patient questionnaire
General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased]
Proportion of patients having a recurrence
Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"

Full Information

First Posted
November 29, 2018
Last Updated
January 15, 2020
Sponsor
Gedea Biotech AB
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1. Study Identification

Unique Protocol Identification Number
NCT03761628
Brief Title
Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis
Official Title
An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Vulvovaginal Candidiasis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gedea Biotech AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiasis
Keywords
Vaginal Yeast Infection, Candidiasis, vulvovaginal, Genital diseases, female, Vaginitis, Vulvovaginitis, Vaginal diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pHyph, Gedea Pessary
Arm Type
Experimental
Arm Description
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.
Intervention Type
Device
Intervention Name(s)
pHyph, Gedea pessary
Intervention Description
pHyph is a vaginal tablet for the treatment of VVC
Primary Outcome Measure Information:
Title
Clinical cure rate
Description
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) = mild (slight) = moderate (definitely present) = severe (marked, intense)
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Proportion of patients having a reduction in CVVS score
Description
Scoring scale as above
Time Frame
Day 7 compared to Day 0
Title
Usability, measured by patient questionnaire
Description
General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased]
Time Frame
Day 7
Title
Proportion of patients having a recurrence
Description
Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"
Time Frame
Up to day 42

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika Cardell, MD, PhD
Organizational Affiliation
Kvinnokliniken, Region Skåne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoftekliniken
City
Helsingborg
Country
Sweden
Facility Name
Annerokliniken
City
Hofterup
Country
Sweden

12. IPD Sharing Statement

Links:
URL
http://gedeabiotech.com
Description
Sponsor webpage

Learn more about this trial

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

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