<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/NCT01730989</url>
  </required_header>
  <id_info>
    <org_study_id>ESP-CPR-0312</org_study_id>
    <nct_id>NCT01730989</nct_id>
  </id_info>
  <brief_title>Estromineral Serena Plus and Symptomatic Menopause</brief_title>
  <official_title>Controlled Clinical Study on the Activity of the Combination of Isoflavones, Agnocastus and Magnolia Extract in Menopause</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rottapharm</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rottapharm</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Oestrogen hormone deficiency in menopause leads to symptoms of which hot flushes, night&#xD;
      sweats, insomnia and mood changes are the most frequent and, ultimately, worsen the quality&#xD;
      of life. The gradual decline of oestrogen from peri-menopause results in altered function of&#xD;
      many neurotransmitters, such as dopamine, melatonin and neuropeptides including&#xD;
      beta-endorphins, which modulate the function of the hypothalamus and are involved in body&#xD;
      thermoregulation.&#xD;
&#xD;
      In post-menopause, dopaminergic activity is significantly reduced and stimulus of the D2&#xD;
      receptors is effective in relieving hot flushes and in reducing the accompanying&#xD;
      psychological symptoms.&#xD;
&#xD;
      The use of hormone replacement therapy, which is generally prescribed in the case of moderate&#xD;
      or severe symptoms, is limited due to real contraindications or simply the woman's refusal to&#xD;
      take the therapy, despite the presence of symptoms requiring its use.&#xD;
&#xD;
      A food supplement, named Estromineral (E), based on natural ingredients such as isoflavones,&#xD;
      the absorption of which is increased by the presence of Lactobacillus sporogenes, and Vitamin&#xD;
      D3 and calcium, strengthening bone mineralization, has been found to be effective at reducing&#xD;
      vasomotor symptoms.&#xD;
&#xD;
      To potentiate the effect of E on the most frequent symptoms in menopause, it was considered&#xD;
      rational to add the extracts of magnolia, active on psycho-affective symptoms, and chaste&#xD;
      tree, acting on both hot flushes and psychological symptoms and a new food supplement was&#xD;
      developed: Estromineral Serena Plus (ESP).&#xD;
&#xD;
      Estromineral Serena Plus is an association of isoflavones with added Lactobacillus, chaste&#xD;
      tree and magnolia, active on menopausal vasomotor symptoms and on psycho-affective symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">November 2013</completion_date>
  <primary_completion_date type="Anticipated">November 2013</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>Kupperman index</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>To calculate the Kupperman index, the symptoms were weighted as follows: hot flashes (4), insomnia (2), nervousness (2), and all other symptoms (night sweats, depressed mood (melancholy), dizziness, tiredness, joint and muscular pain, headache, and palpitations (1). The highest potential score is thus 51. The score of hot flashes was based on number of complaints per day: slight (more than 5), moderate (5-10), and severe (more than 10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>4, 8 and 12 weeks</time_frame>
    <description>Onset duration and severity of adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Menopause</condition>
  <arm_group>
    <arm_group_label>Estromineral Serena Plus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Estromineral Serena Plus is an association of soy isoflavones, Lactobacillus sporogenes, magnolia, chaste tree, Vitamin D3, calcium and magnesium.&#xD;
1 tablet oad for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Estromineral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Estromineral is an association of soy isoflavones, Lactobacillus sporogenes, Vitamin D3, and calcium.&#xD;
1 tablet oad for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Estromineral Serena Plus</intervention_name>
    <arm_group_label>Estromineral Serena Plus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Estromineral</intervention_name>
    <arm_group_label>Estromineral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female menopausal age&#xD;
&#xD;
          -  more than 5 hot flushes/day&#xD;
&#xD;
          -  mood or sleep changes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hormone replacement therapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincenzo De Leo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Siena University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Siena University</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <investigator>
      <last_name>Vincenzo De Leo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 20, 2012</last_update_submitted>
  <last_update_submitted_qc>November 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>menopause</keyword>
  <keyword>Kupperman</keyword>
  <keyword>hot flushes</keyword>
  <keyword>isoflavones</keyword>
  <keyword>magnolia</keyword>
  <keyword>chaste tree</keyword>
  <!-- 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/NCT01730989
org study id: ESP-CPR-0312
nct id: NCT01730989
lead sponsor: 
has dmc: No
Oestrogen hormone deficiency in menopause leads to symptoms of which hot flushes, night
      sweats, insomnia and mood changes are the most frequent and, ultimately, worsen the quality
      of life. The gradual decline of oestrogen from peri-menopause results in altered function of
      many neurotransmitters, such as dopamine, melatonin and neuropeptides including
      beta-endorphins, which modulate the function of the hypothalamus and are involved in body
      thermoregulation.

      In post-menopause, dopaminergic activity is significantly reduced and stimulus of the D2
      receptors is effective in relieving hot flushes and in reducing the accompanying
      psychological symptoms.

      The use of hormone replacement therapy, which is generally prescribed in the case of moderate
      or severe symptoms, is limited due to real contraindications or simply the woman's refusal to
      take the therapy, despite the presence of symptoms requiring its use.

      A food supplement, named Estromineral (E), based on natural ingredients such as isoflavones,
      the absorption of which is increased by the presence of Lactobacillus sporogenes, and Vitamin
      D3 and calcium, strengthening bone mineralization, has been found to be effective at reducing
      vasomotor symptoms.

      To potentiate the effect of E on the most frequent symptoms in menopause, it was considered
      rational to add the extracts of magnolia, active on psycho-affective symptoms, and chaste
      tree, acting on both hot flushes and psychological symptoms and a new food supplement was
      developed: Estromineral Serena Plus (ESP).

      Estromineral Serena Plus is an association of isoflavones with added Lactobacillus, chaste
      tree and magnolia, active on menopausal vasomotor symptoms and on psycho-affective symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Kupperman index
time frame: up to 12 weeks
description: To calculate the Kupperman index, the symptoms were weighted as follows: hot flashes (4), insomnia (2), nervousness (2), and all other symptoms (night sweats, depressed mood (melancholy), dizziness, tiredness, joint and muscular pain, headache, and palpitations (1). The highest potential score is thus 51. The score of hot flashes was based on number of complaints per day: slight (more than 5), moderate (5-10), and severe (more than 10)
measure: Adverse events
time frame: 4, 8 and 12 weeks
description: Onset duration and severity of adverse events
arm group label: Estromineral Serena Plus
arm group type: Experimental
description: Estromineral Serena Plus is an association of soy isoflavones, Lactobacillus sporogenes, magnolia, chaste tree, Vitamin D3, calcium and magnesium.
1 tablet oad for 12 weeks
arm group label: Estromineral
arm group type: Active Comparator
description: Estromineral is an association of soy isoflavones, Lactobacillus sporogenes, Vitamin D3, and calcium.
1 tablet oad for 12 weeks
intervention type: Dietary Supplement
intervention name: Estromineral Serena Plus
arm group label: Estromineral Serena Plus
intervention type: Dietary Supplement
intervention name: Estromineral
arm group label: Estromineral
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: Vincenzo De Leo, MD
role: Principal Investigator
affiliation: Siena University
facility: 
investigator: 
country: Italy
responsible party type: Sponsor