<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03761628</url>
  </required_header>
  <id_info>
    <org_study_id>QRS-CL1-003</org_study_id>
    <nct_id>NCT03761628</nct_id>
  </id_info>
  <brief_title>Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis</brief_title>
  <official_title>An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Vulvovaginal Candidiasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gedea Biotech AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gedea Biotech AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, single-armed, multi-center study to evaluate clinical performance,&#xD;
      tolerability, and safety of Gedea Pessary in 24 adult women with VVC. On Day 0, patients will&#xD;
      have gynecological examination, vaginal samples taken, and will receive the investigational&#xD;
      product to be self-administered. Patients will be examined after 7 days with respect to VVC&#xD;
      signs and symptoms and if not cured, will receive prolonged treatment for one additional&#xD;
      week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal&#xD;
      samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires&#xD;
      will be used for assessing VVC symptoms, usability, and adverse events (AEs).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">January 15, 2020</completion_date>
  <primary_completion_date type="Actual">December 16, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical cure rate</measure>
    <time_frame>Day 7</time_frame>
    <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.&#xD;
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.&#xD;
Vulvovaginal signs: erythema, edema, or excoriation&#xD;
Vulvovaginal symptoms: itching, burning, or irritation&#xD;
Scoring Scale: each score should be objectively defined. 0 = none (absent)&#xD;
= mild (slight)&#xD;
= moderate (definitely present)&#xD;
= severe (marked, intense)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients having a reduction in CVVS score</measure>
    <time_frame>Day 7 compared to Day 0</time_frame>
    <description>Scoring scale as above</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability, measured by patient questionnaire</measure>
    <time_frame>Day 7</time_frame>
    <description>General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients having a recurrence</measure>
    <time_frame>Up to day 42</time_frame>
    <description>Proportion of patients answering [Yes] to the question &quot;Have the symptoms recurred?&quot;</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Vulvovaginal Candidiasis</condition>
  <arm_group>
    <arm_group_label>pHyph, Gedea Pessary</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>pHyph, Gedea pessary</intervention_name>
    <description>pHyph is a vaginal tablet for the treatment of VVC</description>
    <arm_group_label>pHyph, Gedea Pessary</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult, post-menarchal, pre-menopausal women aged 18 years or older&#xD;
&#xD;
          -  Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the&#xD;
             following findings:&#xD;
&#xD;
               1. At least 2 of the following signs and symptoms of VVC that are characterized as&#xD;
                  at least moderate: itching, burning, irritation, edema, redness, or excoriation.&#xD;
&#xD;
               2. Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa&#xD;
                  or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.&#xD;
&#xD;
          -  Having decisional capacity and providing written informed consent&#xD;
&#xD;
          -  Negative urine pregnancy test at screening&#xD;
&#xD;
          -  Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams,&#xD;
             sponges, lubricants, or tampons, etc.) during the study period&#xD;
&#xD;
          -  Refrain from sexual intercourse or use a condom until Day 7&#xD;
&#xD;
          -  Signed informed consent and willing and able to comply with all study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known or apparent signs of other infectious causes of VVC (BV,&#xD;
             Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex,&#xD;
             or human papillomavirus) at screening&#xD;
&#xD;
          -  Patients who are pregnant or breastfeeding&#xD;
&#xD;
          -  Patients who were treated for VVC within the past 14 days&#xD;
&#xD;
          -  Patients who are currently receiving antifungal therapy unrelated to VVC or has taken&#xD;
             antifungal therapy within the past 14 days&#xD;
&#xD;
          -  Patients who have used pH-modifying vaginal products within the last 14 days&#xD;
&#xD;
          -  Patients who have received an investigational drug in a clinical investigation within&#xD;
             30 days prior to screening&#xD;
&#xD;
          -  Known/previous allergy or hypersensitivity to any product constituent or fluconazole&#xD;
&#xD;
          -  Any medical condition that in the Investigator's judgments would make the patient&#xD;
             unsuitable for inclusion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monika Cardell, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kvinnokliniken, Region Skåne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hoftekliniken</name>
      <address>
        <city>Helsingborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Annerokliniken</name>
      <address>
        <city>Hofterup</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://gedeabiotech.com</url>
    <description>Sponsor webpage</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>January 15, 2020</last_update_submitted>
  <last_update_submitted_qc>January 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vaginal Yeast Infection</keyword>
  <keyword>Candidiasis, vulvovaginal</keyword>
  <keyword>Genital diseases, female</keyword>
  <keyword>Vaginitis</keyword>
  <keyword>Vulvovaginitis</keyword>
  <keyword>Vaginal diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Candidiasis</mesh_term>
    <mesh_term>Candidiasis, Vulvovaginal</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03761628
org study id: QRS-CL1-003
nct id: NCT03761628
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical cure rate
time frame: Day 7
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)
measure: Proportion of patients having a reduction in CVVS score
time frame: Day 7 compared to Day 0
description: Scoring scale as above
measure: Usability, measured by patient questionnaire
time frame: Day 7
description: General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased]
measure: Proportion of patients having a recurrence
time frame: Up to day 42
description: Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"
arm group label: pHyph, Gedea Pessary
arm group type: Experimental
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: pHyph, Gedea pessary
description: pHyph is a vaginal tablet for the treatment of VVC
arm group label: pHyph, Gedea Pessary
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Monika Cardell, MD, PhD
role: Principal Investigator
affiliation: Kvinnokliniken, Region Skåne
facility: 
facility: 
country: Sweden
url: http://gedeabiotech.com
description: Sponsor webpage
responsible party type: Sponsor
mesh term: Candidiasis
mesh term: Candidiasis, Vulvovaginal