<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/NCT03820453</url>
  </required_header>
  <id_info>
    <org_study_id>GYN-GFL-01-2018</org_study_id>
    <nct_id>NCT03820453</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.</brief_title>
  <official_title>Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kern Pharma, S.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Analysis and Research Network, S.L</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kern Pharma, S.L.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical Trial will assess the effects of a dietary supplement based on Tribulus&#xD;
      terrestris on the libido and sexual function in postmenopausal women, by doing a follow up of&#xD;
      the FSFI scale and different variables during 3 months period. Participants will be allocated&#xD;
      to dietary supplement or placebo, and will attend to 3 visits (baseline, 6 weeks, 12 weeks&#xD;
      and at 24 weeks optional).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 29, 2018</start_date>
  <completion_date type="Anticipated">August 29, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 29, 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of Score on the Female Sexual Function Index (FSFI)</measure>
    <time_frame>At baseline, at 6 weeks, at 3 months and at 6 months (optional)</time_frame>
    <description>Score on the Female Sexual Function Index (FSFI) Questionnaire on female libido.&#xD;
The scale has 19 questions divided in 6 Domains. Total score ranges from 2 to 36 with higher scores considered better outcome.&#xD;
Scale subdomains, their scoring range and factor to the total score is the following:&#xD;
Domain: Desire, Range [1 - 5] Factor: 0.6 Domain: Arousal, Range [0 - 5] Factor: 0.3 Domain: Lubrication, Range 0 - 5 Factor: 0.3 Domain: Orgasm Range 0 - 5 Factor: 0.4 Domain: Satisfaction Range [0 (or 1) - 5 ] Factor: 0.4 Domain: Pain Range [0-5] Factor: 0.4</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Variations in testosterone levels (total, bioavailable, and free)</measure>
    <time_frame>Change from baseline to 3 months visit</time_frame>
    <description>Testosterone levels (total, bioavailable and free) in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life (QoL) - Measured with Score on the Cervantes Scale.</measure>
    <time_frame>Change from baseline, to 3 months and optional visit at 6 months</time_frame>
    <description>Score on the Cervantes Scale on quality of life.&#xD;
The scale is composed of 31 questions divided in 4 domains. Each question is punctuated from 0 to 5. And total scale result ranges from 0 to 155, where 0 corresponds to the maximun QoL value and 155 worst value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>Thought the study, an average of 10 months.</time_frame>
    <description>Number of adverse events (recorded in the investigator's CRF) to assess the tolerability/safety of the product</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance with treatment - Measured with the Morisky-Green scale</measure>
    <time_frame>3 months</time_frame>
    <description>The Morisky-Green scale measures treatment adherence with four yes or no questions. In which yes punctuates 0 and no punctuates 1.&#xD;
Possible result values for the scale goes from 0 to 4 with 4 being a better outcome than 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance with treatment - Recount of refounded product by patient.</measure>
    <time_frame>3 months</time_frame>
    <description>Recount of product returned at the end of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance with treatment -Therapeutic adherence</measure>
    <time_frame>3 months</time_frame>
    <description>Data will be collected by the investigator at participants visit with a unique question about percentage of intake. It will be considered a good compliance if 80% of the medication has been taken.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Female Sexual Arousal Disorder</condition>
  <arm_group>
    <arm_group_label>Active group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One tablet per day in the morning through oral administration of a dietary supplement containing Tribulus terrestris as the main active ingredient. During three months with the possibility to extend for another three months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One tablet per day in the morning through oral administration of Placebo. During three months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Tribulus Terrestris</intervention_name>
    <description>The experimental arm will receive a dietary supplement to increase the libido and sexual function</description>
    <arm_group_label>Active group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo treatment</intervention_name>
    <description>The control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who report decreased libido and present female sexual arousal disorder according&#xD;
             to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria&#xD;
&#xD;
          -  Post-menopause.&#xD;
&#xD;
          -  Age between 45 and 65 years.&#xD;
&#xD;
          -  Sexually active.&#xD;
&#xD;
          -  Agreement to participate and to sign the informed consent documents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Women who are on hormone replacement therapy or who need to start it.&#xD;
&#xD;
          -  Cancer treatment or a recent history of cancer (&lt;2 years).&#xD;
&#xD;
          -  Any of the following treatments: serotonin inhibitors, GABAergics, tricyclics,&#xD;
             antipsychotics, beta-blockers, thiazide diuretics, dopaminergics and anxiolytics for&#xD;
             chronic problems (patients on treatment with anxiolytics without chronic problems are&#xD;
             eligible)&#xD;
&#xD;
          -  Fibromyalgia.&#xD;
&#xD;
          -  Treatment for, or a history of, oestrogen-dependent cancer (breast, uterus,&#xD;
             endometrium, etc.).&#xD;
&#xD;
          -  Any comorbidity that may interfere with the pathology under study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CAP Manso</name>
      <address>
        <city>Barcelona</city>
        <zip>08015</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fundació Puigvert</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic, Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sexology Institute</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francisca Molero</last_name>
      <phone>+34 934516598</phone>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</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>Sexual Dysfunctions, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03820453
org study id: GYN-GFL-01-2018
nct id: NCT03820453
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This clinical Trial will assess the effects of a dietary supplement based on Tribulus
      terrestris on the libido and sexual function in postmenopausal women, by doing a follow up of
      the FSFI scale and different variables during 3 months period. Participants will be allocated
      to dietary supplement or placebo, and will attend to 3 visits (baseline, 6 weeks, 12 weeks
      and at 24 weeks optional).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Changes of Score on the Female Sexual Function Index (FSFI)
time frame: At baseline, at 6 weeks, at 3 months and at 6 months (optional)
description: Score on the Female Sexual Function Index (FSFI) Questionnaire on female libido.
The scale has 19 questions divided in 6 Domains. Total score ranges from 2 to 36 with higher scores considered better outcome.
Scale subdomains, their scoring range and factor to the total score is the following:
Domain: Desire, Range [1 - 5] Factor: 0.6 Domain: Arousal, Range [0 - 5] Factor: 0.3 Domain: Lubrication, Range 0 - 5 Factor: 0.3 Domain: Orgasm Range 0 - 5 Factor: 0.4 Domain: Satisfaction Range [0 (or 1) - 5 ] Factor: 0.4 Domain: Pain Range [0-5] Factor: 0.4
measure: Variations in testosterone levels (total, bioavailable, and free)
time frame: Change from baseline to 3 months visit
description: Testosterone levels (total, bioavailable and free) in blood
measure: Change in quality of life (QoL) - Measured with Score on the Cervantes Scale.
time frame: Change from baseline, to 3 months and optional visit at 6 months
description: Score on the Cervantes Scale on quality of life.
The scale is composed of 31 questions divided in 4 domains. Each question is punctuated from 0 to 5. And total scale result ranges from 0 to 155, where 0 corresponds to the maximun QoL value and 155 worst value.
measure: Number of adverse events
time frame: Thought the study, an average of 10 months.
description: Number of adverse events (recorded in the investigator's CRF) to assess the tolerability/safety of the product
measure: Compliance with treatment - Measured with the Morisky-Green scale
time frame: 3 months
description: The Morisky-Green scale measures treatment adherence with four yes or no questions. In which yes punctuates 0 and no punctuates 1.
Possible result values for the scale goes from 0 to 4 with 4 being a better outcome than 0.
measure: Compliance with treatment - Recount of refounded product by patient.
time frame: 3 months
description: Recount of product returned at the end of study
measure: Compliance with treatment -Therapeutic adherence
time frame: 3 months
description: Data will be collected by the investigator at participants visit with a unique question about percentage of intake. It will be considered a good compliance if 80% of the medication has been taken.
arm group label: Active group
arm group type: Experimental
description: One tablet per day in the morning through oral administration of a dietary supplement containing Tribulus terrestris as the main active ingredient. During three months with the possibility to extend for another three months.
arm group label: Control group
arm group type: Placebo Comparator
description: One tablet per day in the morning through oral administration of Placebo. During three months.
intervention type: Dietary Supplement
intervention name: Tribulus Terrestris
description: The experimental arm will receive a dietary supplement to increase the libido and sexual function
arm group label: Active group
intervention type: Other
intervention name: Placebo treatment
description: The control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics
arm group label: Control group
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: Sexual Dysfunctions, Psychological
sharing ipd: Undecided