<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/NCT02987647</url>
  </required_header>
  <id_info>
    <org_study_id>HIDRAPILOTO</org_study_id>
    <nct_id>NCT02987647</nct_id>
  </id_info>
  <brief_title>Perception of Efficacy, Safety and Tolerability of Three Non-hormonal Intravaginal Gels and Hormone Cream</brief_title>
  <official_title>Phase IV Pilot, Longitudinal, Prospective, Double-blind, Comparative to Assess the Perception of Efficacy, Safety and Tolerability of Three Non-hormonal Intravaginal Gels and Hormone Cream in Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Farmoquimica S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Farmoquimica S.A.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the perception of the effectiveness of Hidrafemme® gels, Vagidrat®, Lubrinat and&#xD;
      Antrofi cream in improving vaginal moisture in postmenopausal women who are currently&#xD;
      registered options most current and available in the market in order to assess the&#xD;
      differences between them, subsequently conduct a clinical study larger.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before any procedure of the study, the researcher should have undertaken a detailed&#xD;
      discussion on the Consent and Informed remedying any questions the patient may present. Then&#xD;
      the principal investigator and the patient must sign all pages of the Consent and Informed&#xD;
      (two-way), each one with a copy. Female patients aged above 40 years postmenopausal and who&#xD;
      are diagnosed with vaginal dryness, will be invited to participate in this study. After the&#xD;
      selection, through the inclusion and exclusion criteria, and signing the consent form&#xD;
      Clarified, research participants will be evaluated by clinical examination (VHI), pH&#xD;
      evaluation (using pH tape), questionnaire application IFSF and subjective evaluation of the&#xD;
      patient. All the above procedures will be performed in own research center for the study&#xD;
      team. The study in question has four (4) treatment groups with fourteen (14) patients each,&#xD;
      totaling fifty-six (56) patients. The allocation of these patients will occur blind, parallel&#xD;
      to the first group use the Hidrafemme, the second uses the Vagidrat, uses the third and&#xD;
      fourth Lubrinat use the Antrofi. All groups conduct the use of those products, twice a week&#xD;
      for four (4) consecutive weeks. After the addition, the research participant will receive the&#xD;
      product under study and will be oriented as their dosage, correct application form and the&#xD;
      records in the patient diary.&#xD;
&#xD;
      After the Visit 1 (initial) the research participant must return for another visit in person,&#xD;
      Visit 2 (final), the research center, which will take place 28 calendar days after the date&#xD;
      of Visit 1 (initial). During all the above visits, the participants research will be assessed&#xD;
      by the principal investigator and will be conducted the subjective evaluation of the patient,&#xD;
      VHI evaluation (attached), pH control and will fill the IFSF form (attached). At the final&#xD;
      visit will be also evaluated the acceptability of the product and adherence to treatment&#xD;
      through the patient diary. The adverse event occurrences will be evaluated during the final&#xD;
      visit. If any research participant submit an adverse event, it will be accompanied by&#xD;
      research center staff to its resolution. The variables related to the effectiveness of the&#xD;
      product will be studied by VHI scale, which indicates the score of each item under study. The&#xD;
      score should be evaluated for each variable. Daily application for registration throughout&#xD;
      the period of four (4) weeks, and the product will be dispensed after the inclusion /&#xD;
      randomization of the patient during the initial visit, sufficient to twenty-eight (28) days&#xD;
      of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Categories VHI scale for intensity of vaginal moisture</measure>
    <time_frame>28 days</time_frame>
    <description>The efficacy parameter: intensity of vaginal moisture; It will be measured by the VHI: 1 = no / inflamed surface; 2 = no / not inflamed surface; 3 = minimal, 4 = moderate, 5 = Normal. They will be described by mean and standard deviation or median and interquartile range, as well as minimum and maximum. If there is a normal distribution and equal variance will be held the Split-Plot ANOVA measures and where there are significant differences will be a post hoc Tukey and Dunnet. 95% confidence intervals for the mean difference will be calculated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score the increase in Sexual Function Index Women</measure>
    <time_frame>28 days</time_frame>
    <description>The score index of female sexual function (SIFIs) will be described on a monthly basis by mean and standard deviation or median and interquartile range, as well as minimum and maximum. If there is a normal distribution and equal variance will be held the Split-Plot ANOVA test and if there are no significant differences will be performed post hoc Tukey and Dunnet as appropriate. 95% confidence intervals for the mean differences in each visit will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pH vaginal</measure>
    <time_frame>28 days</time_frame>
    <description>It will be measured by its own value, described on a monthly basis by mean and standard deviation or median and interquartile range, as well as minimum and maximum. If there is a normal distribution and equal variance will be held the Split-Plot ANOVA test and if there are no significant differences will be performed post hoc Tukey and Dunnet as appropriate. 95% confidence intervals for the mean differences in each visit will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of the product</measure>
    <time_frame>28 days</time_frame>
    <description>The acceptability of the product will be assessed by the patient using a satisfaction scale: 1 = very satisfied, 2 = satisfied, 3 = makes no difference, 4 = dissatisfied and 5 = very dissatisfied And others.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective patient evaluation</measure>
    <time_frame>28 days</time_frame>
    <description>Patients will assess all visits the intensity of itching and stinging / burning of the vagina on a scale such as: 1 = Severe 2 = Moderate; 3 = mild; 4 = no For the variables: Fire / vaginal burning will be summed up at all visits, in terms of mean and sta or Kruskal-Wallis depending on if there is a normal distribution and equal variance.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Vaginal Dryness</condition>
  <arm_group>
    <arm_group_label>Hidrafemme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The arm in question will have 14 patients who use the Hidrafemme product, encoded as group A.&#xD;
Name: hidrafemme Dosage form: applicator Dosage: the applicator must be complete (full) Frequency: twice a week Duration: 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vagidrat</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The arm in question will have 14 patients who use the Vagidrat product, encoded as group B.&#xD;
Name: vagidrat Dosage form: applicator Dosage: the applicator must be complete (full) Frequency: twice a week Duration: 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lubrinat</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The arm in question will have 14 patients who use the Lubrinat product, encoded as group C.&#xD;
Name: lubrinat Dosage form: applicator Dosage: the applicator must be complete (full) Frequency: twice a week Duration: 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antrofi</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The arm in question will have 14 patients who use the Antrofi product, encoded as group D.&#xD;
Name: antrofi Dosage form: applicator Dosage: the applicator must be complete (full) Frequency: twice a week Duration: 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hidrafemme</intervention_name>
    <description>The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.</description>
    <arm_group_label>Hidrafemme</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vagidrat</intervention_name>
    <description>The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.</description>
    <arm_group_label>Vagidrat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lubrinat</intervention_name>
    <description>The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.</description>
    <arm_group_label>Lubrinat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Antrofi</intervention_name>
    <description>The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.</description>
    <arm_group_label>Antrofi</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women over the age of 40 years.&#xD;
&#xD;
          -  Healthy Women of post-menopausal (no period for more than one year).&#xD;
&#xD;
          -  Women with vaginal dryness.&#xD;
&#xD;
          -  Women with active sex lives of at least 1 sexual intercourse in the month.&#xD;
&#xD;
          -  Women without a history of sensitivity.&#xD;
&#xD;
          -  Understanding and signing the Consent and Informed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women in use of any intravaginal moisturizing gel, vaginal cream and / or spermicide.&#xD;
&#xD;
          -  Women with a diagnosis or history of cancer.&#xD;
&#xD;
          -  Women with disease or condition that, in the opinion of the gynecologist, could affect&#xD;
             the study results.&#xD;
&#xD;
          -  Women using hormone replacement therapy in the last 3 months.&#xD;
&#xD;
          -  History or visible evidence of chronic skin disease or regional infections.&#xD;
&#xD;
          -  History of hypersensitivity (allergy) to promestrieno.&#xD;
&#xD;
          -  Women with genital herpes, vaginal infections or urinary tract infection.&#xD;
&#xD;
          -  Pregnant women and nursing mothers.&#xD;
&#xD;
          -  Allergy Personal history and hypersensitivity to any feminine hygiene product.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thales Braga, analist</last_name>
    <role>Study Director</role>
    <affiliation>FQM</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Camila Abreu, Coordenator</last_name>
    <phone>55 21 969553000</phone>
    <email>cabreu@fqm.com.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fabiene Vale, Investigator</last_name>
    <phone>55 31 99187 8133</phone>
    <email>fabienebcv@yahoo.com.br</email>
  </overall_contact_backup>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02987647
org study id: HIDRAPILOTO
nct id: NCT02987647
lead sponsor: 
has dmc: Yes
To evaluate the perception of the effectiveness of Hidrafemme® gels, Vagidrat®, Lubrinat and
      Antrofi cream in improving vaginal moisture in postmenopausal women who are currently
      registered options most current and available in the market in order to assess the
      differences between them, subsequently conduct a clinical study larger.
Before any procedure of the study, the researcher should have undertaken a detailed
      discussion on the Consent and Informed remedying any questions the patient may present. Then
      the principal investigator and the patient must sign all pages of the Consent and Informed
      (two-way), each one with a copy. Female patients aged above 40 years postmenopausal and who
      are diagnosed with vaginal dryness, will be invited to participate in this study. After the
      selection, through the inclusion and exclusion criteria, and signing the consent form
      Clarified, research participants will be evaluated by clinical examination (VHI), pH
      evaluation (using pH tape), questionnaire application IFSF and subjective evaluation of the
      patient. All the above procedures will be performed in own research center for the study
      team. The study in question has four (4) treatment groups with fourteen (14) patients each,
      totaling fifty-six (56) patients. The allocation of these patients will occur blind, parallel
      to the first group use the Hidrafemme, the second uses the Vagidrat, uses the third and
      fourth Lubrinat use the Antrofi. All groups conduct the use of those products, twice a week
      for four (4) consecutive weeks. After the addition, the research participant will receive the
      product under study and will be oriented as their dosage, correct application form and the
      records in the patient diary.

      After the Visit 1 (initial) the research participant must return for another visit in person,
      Visit 2 (final), the research center, which will take place 28 calendar days after the date
      of Visit 1 (initial). During all the above visits, the participants research will be assessed
      by the principal investigator and will be conducted the subjective evaluation of the patient,
      VHI evaluation (attached), pH control and will fill the IFSF form (attached). At the final
      visit will be also evaluated the acceptability of the product and adherence to treatment
      through the patient diary. The adverse event occurrences will be evaluated during the final
      visit. If any research participant submit an adverse event, it will be accompanied by
      research center staff to its resolution. The variables related to the effectiveness of the
      product will be studied by VHI scale, which indicates the score of each item under study. The
      score should be evaluated for each variable. Daily application for registration throughout
      the period of four (4) weeks, and the product will be dispensed after the inclusion /
      randomization of the patient during the initial visit, sufficient to twenty-eight (28) days
      of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Categories VHI scale for intensity of vaginal moisture
time frame: 28 days
description: The efficacy parameter: intensity of vaginal moisture; It will be measured by the VHI: 1 = no / inflamed surface; 2 = no / not inflamed surface; 3 = minimal, 4 = moderate, 5 = Normal. They will be described by mean and standard deviation or median and interquartile range, as well as minimum and maximum. If there is a normal distribution and equal variance will be held the Split-Plot ANOVA measures and where there are significant differences will be a post hoc Tukey and Dunnet. 95% confidence intervals for the mean difference will be calculated
measure: Score the increase in Sexual Function Index Women
time frame: 28 days
description: The score index of female sexual function (SIFIs) will be described on a monthly basis by mean and standard deviation or median and interquartile range, as well as minimum and maximum. If there is a normal distribution and equal variance will be held the Split-Plot ANOVA test and if there are no significant differences will be performed post hoc Tukey and Dunnet as appropriate. 95% confidence intervals for the mean differences in each visit will be calculated.
measure: pH vaginal
time frame: 28 days
description: It will be measured by its own value, described on a monthly basis by mean and standard deviation or median and interquartile range, as well as minimum and maximum. If there is a normal distribution and equal variance will be held the Split-Plot ANOVA test and if there are no significant differences will be performed post hoc Tukey and Dunnet as appropriate. 95% confidence intervals for the mean differences in each visit will be calculated.
measure: Acceptability of the product
time frame: 28 days
description: The acceptability of the product will be assessed by the patient using a satisfaction scale: 1 = very satisfied, 2 = satisfied, 3 = makes no difference, 4 = dissatisfied and 5 = very dissatisfied And others.
measure: Subjective patient evaluation
time frame: 28 days
description: Patients will assess all visits the intensity of itching and stinging / burning of the vagina on a scale such as: 1 = Severe 2 = Moderate; 3 = mild; 4 = no For the variables: Fire / vaginal burning will be summed up at all visits, in terms of mean and sta or Kruskal-Wallis depending on if there is a normal distribution and equal variance.
arm group label: Hidrafemme
arm group type: Experimental
description: The arm in question will have 14 patients who use the Hidrafemme product, encoded as group A.
Name: hidrafemme Dosage form: applicator Dosage: the applicator must be complete (full) Frequency: twice a week Duration: 28 days
arm group label: Vagidrat
arm group type: Active Comparator
description: The arm in question will have 14 patients who use the Vagidrat product, encoded as group B.
Name: vagidrat Dosage form: applicator Dosage: the applicator must be complete (full) Frequency: twice a week Duration: 28 days
arm group label: Lubrinat
arm group type: Active Comparator
description: The arm in question will have 14 patients who use the Lubrinat product, encoded as group C.
Name: lubrinat Dosage form: applicator Dosage: the applicator must be complete (full) Frequency: twice a week Duration: 28 days
arm group label: Antrofi
arm group type: Active Comparator
description: The arm in question will have 14 patients who use the Antrofi product, encoded as group D.
Name: antrofi Dosage form: applicator Dosage: the applicator must be complete (full) Frequency: twice a week Duration: 28 days
intervention type: Other
intervention name: Hidrafemme
description: The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
arm group label: Hidrafemme
intervention type: Other
intervention name: Vagidrat
description: The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
arm group label: Vagidrat
intervention type: Other
intervention name: Lubrinat
description: The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
arm group label: Lubrinat
intervention type: Other
intervention name: Antrofi
description: The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
arm group label: Antrofi
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Thales Braga, analist
role: Study Director
affiliation: FQM
last name: Camila Abreu, Coordenator
phone: 55 21 969553000
email: cabreu@fqm.com.br
last name: Fabiene Vale, Investigator
phone: 55 31 99187 8133
email: fabienebcv@yahoo.com.br
responsible party type: Sponsor
sharing ipd: No