<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/NCT02994342</url>
  </required_header>
  <id_info>
    <org_study_id>Z7213M02</org_study_id>
    <nct_id>NCT02994342</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness</brief_title>
  <official_title>Efficacy, Tolerability and Safety of a New Medical Device, Zp-025 Vaginal Gel, in the Treatment of Vaginal Dryness in Post-menopausal Women With Vaginal Atrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zambon SpA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zambon SpA</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>
      Evaluation of ZP-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal&#xD;
      dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated&#xD;
      post-menopausal women with vaginal atrophy after 56 consecutive days and at 4-week follow-up&#xD;
      only for women applying ZP-025 vaginal gel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation of ZP-025 vaginal gel in terms of efficacy, tolerability and safety in the&#xD;
      treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a&#xD;
      group of non-treated post-menopausal women with vaginal atrophy for 56 consecutive days.&#xD;
&#xD;
      This trial will be conducted in compliance with last version of Declaration of Helsinki, with&#xD;
      GCP as applicable to investigations with IMD, with the applicable regulatory requirements and&#xD;
      with CRO and Sponsor's SOPs.&#xD;
&#xD;
      This is a multi-centre, national, randomized, controlled vs. no-treatment, open label study&#xD;
      The study will take place in 6 centers of menopause at public Hospitals/Universities. An&#xD;
      ancillary study will be carried on for subjects randomized to ZP-025 group with a follow-up&#xD;
      visit at 4 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in subjective symptoms of total score related to vaginal discomfort</measure>
    <time_frame>56 days</time_frame>
    <description>Change in subjective symptoms of total score related to vaginal discomfort (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, and dyspareunia and vaginal bleeding associated with sexual activity) has been recorded on daily diary by subject from baseline to day 56, evaluated using a subjective evaluation scale (VRS at four items: 0= absent, 1= mild, 2=moderate, 3=severe). Each item is summed up to get to a total symptoms score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of vaginal health index</measure>
    <time_frame>56 days</time_frame>
    <description>change of vaginal health index calculated on the basis of vaginal moistness, vaginal fluid volume, vaginal elasticity, vaginal mucosa, and vaginal pH on a scale ranging from 1 (poorest) to 5 (best) from baseline (day 0), to day 56 recorded by investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of maturation index</measure>
    <time_frame>56 days</time_frame>
    <description>change of maturation index: parabasal, intermediate and superficial cells from baseline (day 0) to day 56</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of Female Sexual Function Index</measure>
    <time_frame>56 days</time_frame>
    <description>change of Female Sexual Function Index (FSFI) from baseline to day 56 in women with at least one sexual intercourse in the treatment period recorded by subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in each subjective symptom score related to vaginal discomfort</measure>
    <time_frame>56 days</time_frame>
    <description>change in each symptom score from baseline to end of study recorded on daily diary by subject(vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, and dyspareunia and vaginal bleeding associated with sexual activity) has been recorded on daily diary by subject from baseline to day 56, evaluated using a subjective evaluation scale (VRS at four items: 0= absent, 1= mild, 2=moderate, 3=severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>local tolerability and incidence of adverse events</measure>
    <time_frame>56 days</time_frame>
    <description>local tolerability registered daily by subject in the subject's diary during the application; period and by the investigator from baseline to day 56; AEs registered over all study period (first patient in - last patient out) - In particular the following assessments will be done: vital signs during all visits. transvaginal ecography to exclude any possible endometrial disease or endometrial thickness variation at the screening visit and at the end of the study, clinical evaluation by the investigator at all visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of Female Sexual Distress Scale-Revised</measure>
    <time_frame>56 days</time_frame>
    <description>change of Female Sexual Distress Scale-Revised (FSDS-R revised 2005) from baseline (Day 0) to day 28 and to the end of the study in women with at least one sexual intercourse in the treatment period recorded by subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of cariopicnotic index (CPI),</measure>
    <time_frame>56 days</time_frame>
    <description>change of cariopicnotic index (CPI), as a correlation of superficial cells with picnotic nuclear and general amount of cells ratio, expressed in percentage from baseline (day 0), to day 56</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Vaginal Dryness</condition>
  <arm_group>
    <arm_group_label>Vaginal gel, Medical Device Class 2A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Every subject has been treated for 56 consecutive days, twice daily with a vaginal application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lifestyle counseling</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Every subject has been observed for 56 consecutive days</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vaginal gel, Medical Device Class 2A</intervention_name>
    <description>Application twice a day of vaginal gel for 56 consecutive days</description>
    <arm_group_label>Vaginal gel, Medical Device Class 2A</arm_group_label>
    <other_name>Monurelle Biogel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  caucasian women &lt;70 years, in physiological postmenopausal status for at least 2&#xD;
             years;&#xD;
&#xD;
          -  women with signs and symptoms of vaginal atrophy (i. e. vaginal discomfort, itching,&#xD;
             dyspareunia, dryness);&#xD;
&#xD;
          -  signed informed consent; willing and able to comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  childbearing potential women;&#xD;
&#xD;
          -  ascertained or presumptive hypersensitivity to the formulation ingredients;&#xD;
&#xD;
          -  therapy with systemic or vaginal oestrogens within 6 months from the inclusion;&#xD;
&#xD;
          -  current urinary or vaginal infection (cultural positive result to vaginal or urines&#xD;
             microbiological swab in the 7 days preceding inclusion);&#xD;
&#xD;
          -  previous episodes of vaginal bleeding or spotting in the last 6 months;&#xD;
&#xD;
          -  vaginal prolapse and any other disease that could interfere with the study conduction&#xD;
             and participation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rossella Nappi, Md PhD</last_name>
    <role>Study Director</role>
    <affiliation>Obstetrics and Gynaecology Clinic IRCCS Fondazione San Matteo University of Pavia, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ospedale San Giovanni di Dio</name>
      <address>
        <city>Cagliari</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Careggi</name>
      <address>
        <city>Firenze</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Macedonio Melloni</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico di Modena</name>
      <address>
        <city>Modena</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Federico II</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>June 27, 2017</last_update_submitted>
  <last_update_submitted_qc>June 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vaginal dryness</keyword>
  <keyword>vaginal gel</keyword>
  <keyword>colostrum</keyword>
  <keyword>vaginal atrophy</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD should be requested to sposnor contacts</ipd_description>
  </patient_data>
  <!-- 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/NCT02994342
org study id: Z7213M02
nct id: NCT02994342
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of ZP-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal
      dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated
      post-menopausal women with vaginal atrophy after 56 consecutive days and at 4-week follow-up
      only for women applying ZP-025 vaginal gel.
Evaluation of ZP-025 vaginal gel in terms of efficacy, tolerability and safety in the
      treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a
      group of non-treated post-menopausal women with vaginal atrophy for 56 consecutive days.

      This trial will be conducted in compliance with last version of Declaration of Helsinki, with
      GCP as applicable to investigations with IMD, with the applicable regulatory requirements and
      with CRO and Sponsor's SOPs.

      This is a multi-centre, national, randomized, controlled vs. no-treatment, open label study
      The study will take place in 6 centers of menopause at public Hospitals/Universities. An
      ancillary study will be carried on for subjects randomized to ZP-025 group with a follow-up
      visit at 4 weeks
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in subjective symptoms of total score related to vaginal discomfort
time frame: 56 days
description: Change in subjective symptoms of total score related to vaginal discomfort (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, and dyspareunia and vaginal bleeding associated with sexual activity) has been recorded on daily diary by subject from baseline to day 56, evaluated using a subjective evaluation scale (VRS at four items: 0= absent, 1= mild, 2=moderate, 3=severe). Each item is summed up to get to a total symptoms score.
measure: change of vaginal health index
time frame: 56 days
description: change of vaginal health index calculated on the basis of vaginal moistness, vaginal fluid volume, vaginal elasticity, vaginal mucosa, and vaginal pH on a scale ranging from 1 (poorest) to 5 (best) from baseline (day 0), to day 56 recorded by investigator
measure: change of maturation index
time frame: 56 days
description: change of maturation index: parabasal, intermediate and superficial cells from baseline (day 0) to day 56
measure: change of Female Sexual Function Index
time frame: 56 days
description: change of Female Sexual Function Index (FSFI) from baseline to day 56 in women with at least one sexual intercourse in the treatment period recorded by subject
measure: change in each subjective symptom score related to vaginal discomfort
time frame: 56 days
description: change in each symptom score from baseline to end of study recorded on daily diary by subject(vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, and dyspareunia and vaginal bleeding associated with sexual activity) has been recorded on daily diary by subject from baseline to day 56, evaluated using a subjective evaluation scale (VRS at four items: 0= absent, 1= mild, 2=moderate, 3=severe).
measure: local tolerability and incidence of adverse events
time frame: 56 days
description: local tolerability registered daily by subject in the subject's diary during the application; period and by the investigator from baseline to day 56; AEs registered over all study period (first patient in - last patient out) - In particular the following assessments will be done: vital signs during all visits. transvaginal ecography to exclude any possible endometrial disease or endometrial thickness variation at the screening visit and at the end of the study, clinical evaluation by the investigator at all visits.
measure: change of Female Sexual Distress Scale-Revised
time frame: 56 days
description: change of Female Sexual Distress Scale-Revised (FSDS-R revised 2005) from baseline (Day 0) to day 28 and to the end of the study in women with at least one sexual intercourse in the treatment period recorded by subject
measure: change of cariopicnotic index (CPI),
time frame: 56 days
description: change of cariopicnotic index (CPI), as a correlation of superficial cells with picnotic nuclear and general amount of cells ratio, expressed in percentage from baseline (day 0), to day 56
arm group label: Vaginal gel, Medical Device Class 2A
arm group type: Active Comparator
description: Every subject has been treated for 56 consecutive days, twice daily with a vaginal application
arm group label: Lifestyle counseling
arm group type: No Intervention
description: Every subject has been observed for 56 consecutive days
intervention type: Device
intervention name: Vaginal gel, Medical Device Class 2A
description: Application twice a day of vaginal gel for 56 consecutive days
arm group label: Vaginal gel, Medical Device Class 2A
other name: Monurelle Biogel
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Rossella Nappi, Md PhD
role: Study Director
affiliation: Obstetrics and Gynaecology Clinic IRCCS Fondazione San Matteo University of Pavia, Italy
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
responsible party type: Sponsor
sharing ipd: Yes
ipd description: IPD should be requested to sposnor contacts