<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/NCT01695616</url>
  </required_header>
  <id_info>
    <org_study_id>ACH-SNT-03(01/12)</org_study_id>
    <nct_id>NCT01695616</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Passiflora Incarnata and Isoflavona Combination in the Treatment of Climacteric Symptoms</brief_title>
  <acronym>Monalisa</acronym>
  <official_title>A Phase III, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Passiflora Incarnata and Isoflavona Combination in the Treatment of Climacteric Symptoms.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ache Laboratorios Farmaceuticos S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ache Laboratorios Farmaceuticos S.A.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effects of Passiflora incarnata and Isoflavone&#xD;
      combination in relieving the symptoms associated with Climacteric Syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is known that Hormone Therapy is recommended postmenopausal women to reduce menopausal&#xD;
      symptoms and prevent osteoporosis frames and cardiovascular disease. However, only 30 to 40%&#xD;
      of women still using hormone therapy.&#xD;
&#xD;
      One reason women do not continue or are reluctant to start Hormone Therapy is realizing that&#xD;
      the prescription of hormones is not a natural situation. Therefore, there is an increased&#xD;
      interest in the use and prescription of estrogen derived from plants, known as&#xD;
      fitoestrogênios.&#xD;
&#xD;
      The development of a drug containing two standardized extracts was focused on two main&#xD;
      symptoms of menopause: hot flashes and anxiety. This product comes from a longing for the&#xD;
      doctors themselves can respond more promptly to patients who reach menopause and who already&#xD;
      has a framework for mild to moderate anxiety.&#xD;
&#xD;
      Thus, to meet the woman who develops menopausal symptoms and that these two are highly&#xD;
      prevalent during menopause, causing intense discomfort routine for this woman, was produced&#xD;
      in association with Soy Passiflora aiming to control anxiety and hot flushes&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2014</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Menopause Rating Scale - MRS</measure>
    <time_frame>104 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kuppperman-Blatt index</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRS scale</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MENQOL</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Climacteric Syndrome</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients enrolled in this arm will take a tablet twice a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Passiflora incarnata and isoflavona combination</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients enrolled in this arm will take a tablet twice a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Active drug</intervention_name>
    <arm_group_label>Passiflora incarnata and isoflavona combination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female amenorrheic for at least one (1) year or surgical menopause since dosage of FSH&#xD;
             ≥ 30 mIU / ml;&#xD;
&#xD;
          -  Age greater than or equal to 40 and less than or equal to 65 years;&#xD;
&#xD;
          -  Cytological examination colpo held at screening visit, Pap cytology classification&#xD;
             with class I and II;&#xD;
&#xD;
          -  By mammography BI-RADS classification (fourth edition) rated one (1) or two (2)&#xD;
             performed at least six (6) months from the time of inclusion in the screening visit or&#xD;
             if the research subject does not present a recent survey ;&#xD;
&#xD;
          -  Line endometrial ≤ 8 mm by transvaginal ultrasound, performed at screening visit, in&#xD;
             the case of subjects who have an intact uterus;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe liver or renal disease at the discretion of the investigator;&#xD;
&#xD;
          -  Hypertension stage III uncontrolled (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg);&#xD;
&#xD;
          -  Important cardiovascular disease such as coronary insufficiency or dilated&#xD;
             cardiomyopathy advanced;&#xD;
&#xD;
          -  Using estrogens, progestins, steroid or hormone replacement therapy (HRT) in the last&#xD;
             3 months;&#xD;
&#xD;
          -  Estrogen-dependent neoplasia;&#xD;
&#xD;
          -  Thromboembolic disorders for less than one year of screening visit;&#xD;
&#xD;
          -  Anabolic drugs use or illicit drug use;&#xD;
&#xD;
          -  Hemoglobin &lt; 10 or &gt; 17 g / dL;&#xD;
&#xD;
          -  TSH &lt; 0, 550 or &gt; 4, 780 UUI / L;&#xD;
&#xD;
          -  FT4 &lt; 0.75 ηg / dL or &gt; 1.8 ηg / dL;&#xD;
&#xD;
          -  Patient that is chronically using MAO inhibitors (MAOIs) or levothyroxine&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ISBEM</name>
      <address>
        <city>São Paulo</city>
        <zip>04062-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>October 18, 2016</last_update_submitted>
  <last_update_submitted_qc>October 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01695616
org study id: ACH-SNT-03(01/12)
nct id: NCT01695616
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the effects of Passiflora incarnata and Isoflavone
      combination in relieving the symptoms associated with Climacteric Syndrome.
It is known that Hormone Therapy is recommended postmenopausal women to reduce menopausal
      symptoms and prevent osteoporosis frames and cardiovascular disease. However, only 30 to 40%
      of women still using hormone therapy.

      One reason women do not continue or are reluctant to start Hormone Therapy is realizing that
      the prescription of hormones is not a natural situation. Therefore, there is an increased
      interest in the use and prescription of estrogen derived from plants, known as
      fitoestrogênios.

      The development of a drug containing two standardized extracts was focused on two main
      symptoms of menopause: hot flashes and anxiety. This product comes from a longing for the
      doctors themselves can respond more promptly to patients who reach menopause and who already
      has a framework for mild to moderate anxiety.

      Thus, to meet the woman who develops menopausal symptoms and that these two are highly
      prevalent during menopause, causing intense discomfort routine for this woman, was produced
      in association with Soy Passiflora aiming to control anxiety and hot flushes
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Menopause Rating Scale - MRS
time frame: 104 days
measure: Kuppperman-Blatt index
time frame: 90 days
measure: MRS scale
time frame: 90 days
measure: MENQOL
time frame: 90 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients enrolled in this arm will take a tablet twice a day
arm group label: Passiflora incarnata and isoflavona combination
arm group type: Active Comparator
description: Patients enrolled in this arm will take a tablet twice a day
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: Active drug
arm group label: Passiflora incarnata and isoflavona combination
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Sponsor