<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/NCT03823560</url>
  </required_header>
  <id_info>
    <org_study_id>CeleMD01</org_study_id>
    <nct_id>NCT03823560</nct_id>
  </id_info>
  <brief_title>Performance and Safety of Class IIb MD Celegyn® in VVA</brief_title>
  <official_title>Evaluation of Performance and Safety of the CE Marked Medical Device Class IIb Celegyn® in Vulvovaginal Atrophy (VVA): a Randomised, Double-blind, Parallel Groups, Multicentric, Placebo-Controlled, Prospective Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nathura S.p.A</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Evidilya S.r.l.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nathura S.p.A</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>
      The aim of this study is primarily to investigate the performance of Celegyn®, a hyaluronic&#xD;
      acid-based vaginal cream (CE marked 0546 medical device), enriched with plant-based&#xD;
      ingredients, in comparison with placebo, in promoting vaginal health in adult woman reporting&#xD;
      symptoms of vulvovaginal atrophy - VVA (or atrophic vulvovaginitis)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 24, 2019</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</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>
    <intervention_model_description>randomised, double-blind, parallel groups, multicentric, placebo-controlled, prospective clinical study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of Vaginal Health Index (VHI)</measure>
    <time_frame>from Day 0 to Day 21</time_frame>
    <description>comparison between groups, mean change from Day 0 to Day 21</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of vulvar signs of VVA assessed by means of vulvoscopy</measure>
    <time_frame>from Day 0 to Day 21</time_frame>
    <description>comparison between groups, mean change from Day 0 to Day 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of vulvar signs of VVA (vaginal secretions, vaginal epithelial integrity, vaginal epithelial surface thickness and vaginal colour, categorized as none, mild, moderate, or severe corresponding to a score of 0, 1, 2 or 3, respectively)</measure>
    <time_frame>from Day 0 to Day 21</time_frame>
    <description>comparison between groups, mean change from Day 0 to Day 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of visible skin signs of irritation such as redness, dryness, scaling, peeling, bumps, hives, categorized as none, mild, moderate, or severe corresponding to a score of 0, 1, 2 or 3, respectively</measure>
    <time_frame>from Day 0 to Day 21</time_frame>
    <description>comparison between groups, mean change from Day 0 to Day 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment done by Investigator of overall improvement by means of Global Assessment of Improvement (GAI - according to a 7-grade scoring system, 0-6)</measure>
    <time_frame>at Day 21</time_frame>
    <description>comparison between groups, at Day 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of subjective vaginal symptoms related to VVA and irritation (dryness, dyspareunia, burning, itching, stinging) by means of 100 mm Visual Analogue Scales</measure>
    <time_frame>from Day 0 to 21</time_frame>
    <description>comparison between groups, mean change from Day 0 to Day 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of global severity score for symptoms of VVA</measure>
    <time_frame>from Day 0 to Day 21</time_frame>
    <description>comparison between groups, mean change from Day 0 to Day 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of dyspareunia by means of the Marinoff Dyspareunia Scale</measure>
    <time_frame>from Day 0 to Day 21</time_frame>
    <description>comparison between groups, mean change from Day 0 to Day 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of pain through the short form of McGill Pain questionnaire</measure>
    <time_frame>from Day 0 to Day 21</time_frame>
    <description>comparison between groups, mean change from Day 0 to Day 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of patient satisfaction, assessed on 0 to 10 points scale (extremely dissatisfied = 0; extremely satisfied = 10)</measure>
    <time_frame>at Day 21</time_frame>
    <description>comparison between groups, at Day 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient willingness to use the product in the future, assessed on 1 - 4 points scale (strongly disagree=1, disagree=2, agree=3, strongly agree=4)</measure>
    <time_frame>at Day 21</time_frame>
    <description>comparison between groups, at Day 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of rescue product use (starting date and number of times the rescue product was used)</measure>
    <time_frame>at Day 21</time_frame>
    <description>comparison among groups, at Day 21</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Vulvovaginal Atrophy</condition>
  <arm_group>
    <arm_group_label>GROUP A: medical device Celegyn®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medical device Celegyn® presents itself as a white ivory cream (cream-like oil-in-water topical emulsion) with a typical smell; it is intended for topical use.&#xD;
Posology: It is to be applied preferably in the evening, once a day, for the first seven days, and every other day until the end of the study (i.e. during the second and third week) according to the following:&#xD;
for external (vulvar) use: it should be applied as needed directly to the affected area with a gentle massage;&#xD;
for internal (vaginal) use: use the vaginal applicators provided and follow the directions of use, according to package insert</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GROUP B: matching placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Investigational Product (IP) placebo presents itself as a white ivory cream (cream-like oil-in-water topical emulsion) with a typical smell; it is intended for topical use.&#xD;
Posology: It is to be applied preferably in the evening, once a day, for the first seven days, and every other day until the end of the study (i.e. during the second and third week) according to the following:&#xD;
for external (vulvar) use: it should be applied as needed directly to the affected area with a gentle massage;&#xD;
for internal (vaginal) use: use the vaginal applicators provided and follow the directions of use, according to package insert</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Celegyn®</intervention_name>
    <description>Medical device Celegyn® presents itself as a cream.</description>
    <arm_group_label>GROUP A: medical device Celegyn®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Matching placebo</intervention_name>
    <description>IP placebo presents itself as a cream.</description>
    <arm_group_label>GROUP B: matching placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female patients aged between 18 and 65 years.&#xD;
&#xD;
          2. Patients reporting vulvovaginal dryness associated with spontaneous pain and / or&#xD;
             dyspareunia (minimum score of 30 on a 100 mm Visual Analogue Scale for both symptoms&#xD;
             referable to vulvovaginal atrophy: dryness and spontaneous pain and / or dyspareunia).&#xD;
&#xD;
          3. Patients sexually active (i.e. women who currently have intercourse or other sexual&#xD;
             activity (masturbation, etc) at least once a month (with or without a partner), or who&#xD;
             had intercourse or other sexual activity at least once a month in the past, but later&#xD;
             decreased sexual activity due to excessive pain or vaginal dryness. Dyspareunia is&#xD;
             defined (2nd International Consultation on Sexual Medicine) as &quot;persistent or&#xD;
             recurrent pain with attempted or complete vaginal entry and/or penile vaginal&#xD;
             intercourse&quot; that is not the result of other abnormalities).&#xD;
&#xD;
          4. Patients agreeing not to use lubricants or other topically applied vaginal products&#xD;
             during the study and not to modify their personal hygiene products.&#xD;
&#xD;
          5. Patients of childbearing potential following a reliable (according to investigator's&#xD;
             opinion) non-hormonal contraception therapy.&#xD;
&#xD;
          6. Patients presenting body mass index between 18.5 and 29.9 kg/m2.&#xD;
&#xD;
          7. Patients with normal Papanicolaou test results (including inflammatory changes) within&#xD;
             the past 12 months after specimen collection.&#xD;
&#xD;
          8. Willingness to participate in the study and to sign an informed consent form.&#xD;
&#xD;
          9. No past or present narcotic addiction or alcoholism.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients presenting vulvar or vaginal pathology other than vulvovaginal atrophy.&#xD;
&#xD;
          2. Patients pregnant or breastfeeding.&#xD;
&#xD;
          3. Patients presenting undiagnosed abnormal genital bleeding.&#xD;
&#xD;
          4. Patients presenting endometrial pathology, such as hyperplasia (endometriosis) or&#xD;
             endometrial polyps, cancer, palpable fibroids or grade 2 uterine prolapse (when the&#xD;
             cervix reaches the labia minora) on gynaecologic examination.&#xD;
&#xD;
          5. Patients presenting coagulation disorders or on anticoagulant drug therapy (except&#xD;
             clopidogrel or acetylsalicylic acid).&#xD;
&#xD;
          6. Patients diagnosed with clinically significant metabolic or endocrine disease or&#xD;
             diabetes mellitus uncontrolled by medication.&#xD;
&#xD;
          7. Patients diagnosed with hypertension and in treatment with antihypertensive&#xD;
             medications.&#xD;
&#xD;
          8. Patients diagnosed with severe renal and/or hepatic insufficiency.&#xD;
&#xD;
          9. Patients who have changed or started systemic oestrogen - progestin or hormone therapy&#xD;
             in the 3 months prior to inclusion (including contraceptive therapy (pill) or&#xD;
             Substitutive Hormonal Therapy (SHT)).&#xD;
&#xD;
         10. Patients on systemic chronic oestrogen - progestin therapy (including contraceptive&#xD;
             therapy (pill) or Substitutive Hormonal Therapy (SHT)).&#xD;
&#xD;
         11. Patients in treatment with the following systemic drug: nonsteroidal anti-inflammatory&#xD;
             drugs, antihistamines, corticosteroids in the 2 weeks prior to inclusion,&#xD;
             immunosuppressants in the 3 months prior to inclusion, venotonic or diuretic agents in&#xD;
             the month prior to inclusion.&#xD;
&#xD;
         12. Patients using topic oestrogen - progestin or hormonal therapy, in the week prior to&#xD;
             inclusion.&#xD;
&#xD;
         13. Patients in treatment with topically applied vaginal products, including medications&#xD;
             to promote healing, in the week prior to inclusion.&#xD;
&#xD;
         14. Patients that participated in any other clinical trial during the last month or&#xD;
             participating in any clinical trial while participating in this trial.&#xD;
&#xD;
         15. Patients reporting allergy or intolerance to any component of test product, placebo or&#xD;
             rescue product.&#xD;
&#xD;
         16. Smoking patients.&#xD;
&#xD;
         17. Patients who in the opinion of the principal investigator are at risk of&#xD;
             non-compliance to the study procedures or who are otherwise not appropriate to include&#xD;
             in this clinical trial.&#xD;
&#xD;
         18. Patients presenting contraindications to the rescue product, according to concerning&#xD;
             Summary of Product Characteristics (SPC).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Antonio Bertolino, PhD</last_name>
    <phone>+390249530065</phone>
    <email>antonio.bertolino@evidilya.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cesare Mutti</last_name>
    <phone>+390249530065</phone>
    <email>cesare.mutti@evidilya.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Spedali Civili di Brescia</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Franco Odicino, Prof</last_name>
      <phone>+390303995341</phone>
      <email>franco.odicino@unibs.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milan</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eleonora P Preti, MD</last_name>
      <phone>+390257489616</phone>
      <email>eleonora.preti@ieo.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rossella E Nappi, Prof</last_name>
      <email>r.nappi@smatteo.pv.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 5, 2021</last_update_submitted>
  <last_update_submitted_qc>January 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 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>Atrophy</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/NCT03823560
org study id: CeleMD01
nct id: NCT03823560
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is primarily to investigate the performance of Celegyn®, a hyaluronic
      acid-based vaginal cream (CE marked 0546 medical device), enriched with plant-based
      ingredients, in comparison with placebo, in promoting vaginal health in adult woman reporting
      symptoms of vulvovaginal atrophy - VVA (or atrophic vulvovaginitis)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomised, double-blind, parallel groups, multicentric, placebo-controlled, prospective clinical study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Assessment of Vaginal Health Index (VHI)
time frame: from Day 0 to Day 21
description: comparison between groups, mean change from Day 0 to Day 21
measure: Assessment of vulvar signs of VVA assessed by means of vulvoscopy
time frame: from Day 0 to Day 21
description: comparison between groups, mean change from Day 0 to Day 21
measure: Assessment of vulvar signs of VVA (vaginal secretions, vaginal epithelial integrity, vaginal epithelial surface thickness and vaginal colour, categorized as none, mild, moderate, or severe corresponding to a score of 0, 1, 2 or 3, respectively)
time frame: from Day 0 to Day 21
description: comparison between groups, mean change from Day 0 to Day 21
measure: Assessment of visible skin signs of irritation such as redness, dryness, scaling, peeling, bumps, hives, categorized as none, mild, moderate, or severe corresponding to a score of 0, 1, 2 or 3, respectively
time frame: from Day 0 to Day 21
description: comparison between groups, mean change from Day 0 to Day 21
measure: Assessment done by Investigator of overall improvement by means of Global Assessment of Improvement (GAI - according to a 7-grade scoring system, 0-6)
time frame: at Day 21
description: comparison between groups, at Day 21
measure: Assessment of subjective vaginal symptoms related to VVA and irritation (dryness, dyspareunia, burning, itching, stinging) by means of 100 mm Visual Analogue Scales
time frame: from Day 0 to 21
description: comparison between groups, mean change from Day 0 to Day 21
measure: Assessment of global severity score for symptoms of VVA
time frame: from Day 0 to Day 21
description: comparison between groups, mean change from Day 0 to Day 21
measure: Assessment of dyspareunia by means of the Marinoff Dyspareunia Scale
time frame: from Day 0 to Day 21
description: comparison between groups, mean change from Day 0 to Day 21
measure: Assessment of pain through the short form of McGill Pain questionnaire
time frame: from Day 0 to Day 21
description: comparison between groups, mean change from Day 0 to Day 21
measure: Assessment of patient satisfaction, assessed on 0 to 10 points scale (extremely dissatisfied = 0; extremely satisfied = 10)
time frame: at Day 21
description: comparison between groups, at Day 21
measure: Patient willingness to use the product in the future, assessed on 1 - 4 points scale (strongly disagree=1, disagree=2, agree=3, strongly agree=4)
time frame: at Day 21
description: comparison between groups, at Day 21
measure: Assessment of rescue product use (starting date and number of times the rescue product was used)
time frame: at Day 21
description: comparison among groups, at Day 21
arm group label: GROUP A: medical device Celegyn®
arm group type: Experimental
description: Medical device Celegyn® presents itself as a white ivory cream (cream-like oil-in-water topical emulsion) with a typical smell; it is intended for topical use.
Posology: It is to be applied preferably in the evening, once a day, for the first seven days, and every other day until the end of the study (i.e. during the second and third week) according to the following:
for external (vulvar) use: it should be applied as needed directly to the affected area with a gentle massage;
for internal (vaginal) use: use the vaginal applicators provided and follow the directions of use, according to package insert
arm group label: GROUP B: matching placebo
arm group type: Placebo Comparator
description: Investigational Product (IP) placebo presents itself as a white ivory cream (cream-like oil-in-water topical emulsion) with a typical smell; it is intended for topical use.
Posology: It is to be applied preferably in the evening, once a day, for the first seven days, and every other day until the end of the study (i.e. during the second and third week) according to the following:
for external (vulvar) use: it should be applied as needed directly to the affected area with a gentle massage;
for internal (vaginal) use: use the vaginal applicators provided and follow the directions of use, according to package insert
intervention type: Device
intervention name: Celegyn®
description: Medical device Celegyn® presents itself as a cream.
arm group label: GROUP A: medical device Celegyn®
intervention type: Device
intervention name: Matching placebo
description: IP placebo presents itself as a cream.
arm group label: GROUP B: matching placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Antonio Bertolino, PhD
phone: +390249530065
email: antonio.bertolino@evidilya.com
last name: Cesare Mutti
phone: +390249530065
email: cesare.mutti@evidilya.com
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor
mesh term: Atrophy