<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/NCT03762083</url>
  </required_header>
  <id_info>
    <org_study_id>QRS-CL2-003</org_study_id>
    <nct_id>NCT03762083</nct_id>
  </id_info>
  <brief_title>Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis</brief_title>
  <official_title>An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Bacterial Vaginosis</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 confirmed BV according to&#xD;
      fulfillment of at least 3 of the 4 Amsel criteria. On Day 0, patients will have gynecological&#xD;
      examination, vaginal samples taken, and will receive the investigational product to be&#xD;
      self-administered. Patients will be examined after 7 days with respect to 3 Amsel criteria&#xD;
      (the criterion: &quot;pH of vaginal fluid above 4.5&quot; is only included at study inclusion for&#xD;
      diagnosis), and if not cured, will receive prolonged treatment for one additional week.&#xD;
      Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples&#xD;
      will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be&#xD;
      used for assessing BV 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">November 18, 2019</completion_date>
  <primary_completion_date type="Actual">October 22, 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 absence of all of the following 3 Amsel criteria:&#xD;
Thin, white, yellow, homogenous discharge&#xD;
Clue cells on microscopy (more than 20% of epithelial cells)&#xD;
Release of fishy odor &quot;i.e. a positive whiff test&quot; when alkali (10% potassium hydroxide [KOH] solution) is added</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients being negative for each of the 3 Amsel criteria</measure>
    <time_frame>Day 7 compared to Day 0</time_frame>
    <description>Defined as absence of the following Amsel criteria:&#xD;
Thin, white, yellow, homogenous discharge&#xD;
Clue cells on microscopy (more than 20% of epithelial cells)&#xD;
Release of fishy odor &quot;i.e. a positive whiff test&quot; when alkali (10% potassium hydroxide [KOH] solution) is added</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 of the BV</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>Bacterial Vaginosis</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 BV.</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 BV.</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 BV according to Amsel's criteria, defined as having at least 3 of the 4&#xD;
             following criteria:&#xD;
&#xD;
               1. Thin, white, yellow, homogenous discharge&#xD;
&#xD;
               2. Clue cells on microscopy (more than 20 percent of epithelial cells)&#xD;
&#xD;
               3. pH of vaginal fluid above 4.5&#xD;
&#xD;
               4. Release of fishy odor &quot;i.e. a positive whiff test&quot; when alkali (10% potassium&#xD;
                  hydroxide [KOH] solution) is added&#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 BV (vulvovaginal&#xD;
        candidiasis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes&#xD;
        simplex, or human papillomavirus) at screening&#xD;
&#xD;
          -  Anticipated menstruation during the treatment period (Day 0 till Day 7)&#xD;
&#xD;
          -  Patients who are pregnant or breastfeeding&#xD;
&#xD;
          -  Patients who were treated for BV within the past 14 days&#xD;
&#xD;
          -  Patients who are currently receiving antibiotic therapy unrelated to BV or have&#xD;
             received antibiotic 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&#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>Stortorgets Gynekologmottagning</name>
      <address>
        <city>Helsingborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sophiakliniken</name>
      <address>
        <city>Lund</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>November 2019</verification_date>
  <study_first_submitted>November 30, 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>November 21, 2019</last_update_submitted>
  <last_update_submitted_qc>November 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vaginitis</keyword>
  <keyword>vaginal disease</keyword>
  <keyword>vulvovaginitis</keyword>
  <keyword>genital disease, female</keyword>
  <keyword>vaginitis, bacterial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaginosis, Bacterial</mesh_term>
    <mesh_term>Vaginal Diseases</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/NCT03762083
org study id: QRS-CL2-003
nct id: NCT03762083
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 confirmed BV according to
      fulfillment of at least 3 of the 4 Amsel criteria. 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 3 Amsel criteria
      (the criterion: "pH of vaginal fluid above 4.5" is only included at study inclusion for
      diagnosis), 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 BV 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 absence of all of the following 3 Amsel criteria:
Thin, white, yellow, homogenous discharge
Clue cells on microscopy (more than 20% of epithelial cells)
Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added
measure: Proportion of patients being negative for each of the 3 Amsel criteria
time frame: Day 7 compared to Day 0
description: Defined as absence of the following Amsel criteria:
Thin, white, yellow, homogenous discharge
Clue cells on microscopy (more than 20% of epithelial cells)
Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added
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 of the BV
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 BV.
intervention type: Device
intervention name: pHyph, Gedea pessary
description: pHyph is a vaginal tablet for the treatment of BV.
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: Vaginosis, Bacterial
mesh term: Vaginal Diseases