<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/NCT04489290</url>
  </required_header>
  <id_info>
    <org_study_id>Piva01</org_study_id>
    <nct_id>NCT04489290</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis</brief_title>
  <official_title>A Randomised, Double-blind, and Placebo-controlled Post Market Clinical Follow-Up Investigation to Investigate the Clinical Performance of a Medical Device on Clinical Signs and Symptoms in Patients With Bacterial Vaginosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pharmiva AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LINK Medical Research AB</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CPS Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Scandinavian Development Services AB</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pharmiva 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 a randomised, double-blind clinical investigation to evaluate the efficacy and safety&#xD;
      of D005 vaginal mousse compared to placebo, in women with bacterial vaginosis.&#xD;
&#xD;
      The study will be conducted at one site in Scotland, United Kingdom. The study population&#xD;
      will consist of approximately 96 female subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 12, 2021</start_date>
  <completion_date type="Anticipated">June 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical cure rate</measure>
    <time_frame>23 to 28 days after last dosing</time_frame>
    <description>Clinical cure defined as absence of all of the following 3 Amsel criteria:&#xD;
Off-white (milky or gray), thin, homogeneous discharge.&#xD;
The presence of clue cells greater than 20% of the total epithelial cells on microscopic examination.&#xD;
A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of KOH.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical cure rate</measure>
    <time_frame>1 to 3 days after last dosing</time_frame>
    <description>Clinical cure defined as absence of all of the following 3 Amsel criteria:&#xD;
Off-white (milky or gray), thin, homogeneous discharge.&#xD;
The presence of clue cells greater than 20% of the total epithelial cells on microscopic examination.&#xD;
A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of KOH.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nugent score &lt;4</measure>
    <time_frame>1 to 3 days after last dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nugent score &lt;4</measure>
    <time_frame>23 to 28 days after last dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical cure + Nugent score &lt;4</measure>
    <time_frame>1 to 3 days after last dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical cure + Nugent score &lt;4</measure>
    <time_frame>23 to 28 days after last dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment</measure>
    <time_frame>1 to 3 days after last dosing</time_frame>
    <description>Vaginal malodour, discharge and itch will be graded as the following:&#xD;
Vaginal malodour 0 = normal, 1 = mild, 2 = moderate, 3 = severe Discharge 0 = normal, 1 = mild, 2 = moderate Itch 0 = normal, 1 = mild, 2 = moderate, 3 = severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment</measure>
    <time_frame>23 to 28 days after last dosing</time_frame>
    <description>Vaginal malodour, discharge and itch will be graded as the following:&#xD;
Vaginal malodour 0 = normal, 1 = mild, 2 = moderate, 3 = severe Discharge 0 = normal, 1 = mild, 2 = moderate Itch 0 = normal, 1 = mild, 2 = moderate, 3 = severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pH of the vaginal fluid</measure>
    <time_frame>Day 1-7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pH of the vaginal fluid</measure>
    <time_frame>1 to 3 days after last dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pH of the vaginal fluid</measure>
    <time_frame>23 to 28 days after last dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absence of clue cells</measure>
    <time_frame>1 to 3 days after last dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absence of clue cells</measure>
    <time_frame>23 to 28 days after last dosing</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Bacterial Vaginoses</condition>
  <arm_group>
    <arm_group_label>D005 Vaginal Mousse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>D005 Vaginal Mousse</intervention_name>
    <description>D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.</description>
    <arm_group_label>D005 Vaginal Mousse</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Willingness and ability to provide informed consent&#xD;
&#xD;
          2. Female in fertile age&#xD;
&#xD;
          3. Age ≥16 years&#xD;
&#xD;
          4. Nugent score ≥7&#xD;
&#xD;
          5. Bacterial vaginosis, as defined by the following criteria (Amsel criteria):&#xD;
&#xD;
               1. pH of vaginal fluid &gt;4.5&#xD;
&#xD;
               2. Positive amine test&#xD;
&#xD;
               3. Presence of clue cells&#xD;
&#xD;
               4. Presence of characteristic, homogenous vaginal discharge&#xD;
&#xD;
          6. Refrain from using any intravaginal products during the investigation period&#xD;
&#xD;
          7. Refrain from sexual intercourse during treatment. Refrain from sexual intercourse or&#xD;
             use a condom during rest of the investigation period to Visit 3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity or allergy to the investigational devices or to chemically related&#xD;
             products&#xD;
&#xD;
          2. Current use of an intrauterine device&#xD;
&#xD;
          3. Irregular menstruation cycle (21-35 days considered normal). Note that women with&#xD;
             amenorrhea are considered eligible.&#xD;
&#xD;
          4. Current pregnancy or intention to become pregnant within 1 month after treatment&#xD;
&#xD;
          5. Antibiotic treatment within 2 weeks before treatment&#xD;
&#xD;
          6. Signs of other infections (such as chlamydia, gonorrhoea, trichomonas, candida, HSV or&#xD;
             HPV) requiring specific antibiotic, antifungal or other treatment at screening.&#xD;
&#xD;
          7. Immunosuppression&#xD;
&#xD;
          8. Existing or suspected vaginal or cervical cancer or ulcer 9 Unprotected vaginal sex&#xD;
             within 24 hours prior to Visit 1&#xD;
&#xD;
        10. Be identified by the Investigator as inappropriate to participate in this investigation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CPS Research</name>
      <address>
        <city>Glasgow</city>
        <state>Scottland</state>
        <zip>G20 0XA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gordon Crawford, DR</last_name>
      <phone>+44 141 946 7888</phone>
      <email>gordon.crawford@cpsresearch.co.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>September 2, 2021</last_update_submitted>
  <last_update_submitted_qc>September 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04489290
org study id: Piva01
nct id: NCT04489290
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomised, double-blind clinical investigation to evaluate the efficacy and safety
      of D005 vaginal mousse compared to placebo, in women with bacterial vaginosis.

      The study will be conducted at one site in Scotland, United Kingdom. The study population
      will consist of approximately 96 female subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Clinical cure rate
time frame: 23 to 28 days after last dosing
description: Clinical cure defined as absence of all of the following 3 Amsel criteria:
Off-white (milky or gray), thin, homogeneous discharge.
The presence of clue cells greater than 20% of the total epithelial cells on microscopic examination.
A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of KOH.
measure: Clinical cure rate
time frame: 1 to 3 days after last dosing
description: Clinical cure defined as absence of all of the following 3 Amsel criteria:
Off-white (milky or gray), thin, homogeneous discharge.
The presence of clue cells greater than 20% of the total epithelial cells on microscopic examination.
A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of KOH.
measure: Nugent score <4
time frame: 1 to 3 days after last dosing
measure: Nugent score <4
time frame: 23 to 28 days after last dosing
measure: Clinical cure + Nugent score <4
time frame: 1 to 3 days after last dosing
measure: Clinical cure + Nugent score <4
time frame: 23 to 28 days after last dosing
measure: Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment
time frame: 1 to 3 days after last dosing
description: Vaginal malodour, discharge and itch will be graded as the following:
Vaginal malodour 0 = normal, 1 = mild, 2 = moderate, 3 = severe Discharge 0 = normal, 1 = mild, 2 = moderate Itch 0 = normal, 1 = mild, 2 = moderate, 3 = severe
measure: Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment
time frame: 23 to 28 days after last dosing
description: Vaginal malodour, discharge and itch will be graded as the following:
Vaginal malodour 0 = normal, 1 = mild, 2 = moderate, 3 = severe Discharge 0 = normal, 1 = mild, 2 = moderate Itch 0 = normal, 1 = mild, 2 = moderate, 3 = severe
measure: pH of the vaginal fluid
time frame: Day 1-7
measure: pH of the vaginal fluid
time frame: 1 to 3 days after last dosing
measure: pH of the vaginal fluid
time frame: 23 to 28 days after last dosing
measure: Absence of clue cells
time frame: 1 to 3 days after last dosing
measure: Absence of clue cells
time frame: 23 to 28 days after last dosing
arm group label: D005 Vaginal Mousse
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Device
intervention name: D005 Vaginal Mousse
description: D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.
arm group label: D005 Vaginal Mousse
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Vaginosis, Bacterial
mesh term: Vaginal Diseases