<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/NCT03285672</url>
  </required_header>
  <id_info>
    <org_study_id>FERV001</org_study_id>
    <nct_id>NCT03285672</nct_id>
  </id_info>
  <brief_title>FP-101 for the Treatment of Hot Flashes in Postmenopausal Women</brief_title>
  <official_title>A Phase 2, Randomized, Double-blind, Placebo Controlled, Single Dose-level, Proof-of-concept Study Evaluating FP-101 for the Treatment of Vasomotor Symptoms in Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fervent Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Iqvia Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fervent Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the efficacy of FP-101 versus placebo for the&#xD;
      treatment of hot flashes in postmenopausal women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vasomotor symptoms, commonly known as hot flashes or hot flushes, are the most common&#xD;
      symptoms experienced by women who are perimenopausal or postmenopausal. FP-101 is postulated&#xD;
      to mediate one of the mechanisms thought to drive hot flashes in post-menopausal women. This&#xD;
      study will evaluate the efficacy and safety of FP-101 for the treatment of hot flashes in&#xD;
      post-menopausal women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 26, 2018</start_date>
  <completion_date type="Actual">October 29, 2018</completion_date>
  <primary_completion_date type="Actual">October 29, 2018</primary_completion_date>
  <phase>Phase 2</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>The primary efficacy endpoint for the main study is the change in the frequency of moderate-to-severe hot flashes.</measure>
    <time_frame>Baseline to Week 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the severity of moderate-to-severe hot flashes.</measure>
    <time_frame>Baseline to Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the severity of moderate-to-severe hot flashes.</measure>
    <time_frame>Baseline to Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the frequency of moderate-to-severe hot flashes.</measure>
    <time_frame>Baseline to Week 4</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Hot Flashes</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FP-101</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Comparator</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FP-101</intervention_name>
    <description>Dose 1</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Comparator</intervention_name>
    <description>Dose 1</description>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects may be enrolled in the main study only if they meet all of the following criteria:&#xD;
&#xD;
          -  Subject must be a female &gt;40 years of age at screening.&#xD;
&#xD;
          -  Subject must have reported more than 7 to 8 moderate-to-severe hot flashes per day or&#xD;
             50 to 60 hot flashes per week for at least 30 days prior to the Screening Visit of&#xD;
             sufficient severity to cause desire for therapeutic intervention.&#xD;
&#xD;
          -  Subject must meet 1 of the following criteria:&#xD;
&#xD;
               -  Spontaneous amenorrhea for at least 12 consecutive months.&#xD;
&#xD;
               -  Amenorrhea for at least 6 months and meet the biochemical criteria for menopause&#xD;
                  (FSH ≥40 mIU/mL).&#xD;
&#xD;
               -  Bilateral oophorectomy or salpingo-oophorectomy ≥6 weeks prior to enrollment with&#xD;
                  or without hysterectomy.&#xD;
&#xD;
          -  A subject who is not at least 2 years postmenopausal must use adequate nonhormonal&#xD;
             contraception (eg, barrier methods such as an intrauterine device, diaphragm, cervical&#xD;
             cap, or condom) during study participation.&#xD;
&#xD;
          -  Subject must be willing and able to be compliant with the protocol and provide a&#xD;
             voluntary written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a history of hypersensitivity or adverse reaction to FP-101 or its&#xD;
             excipients&#xD;
&#xD;
          -  Subject is a known non-responder to previous SSRI or SNRI treatment for VMS&#xD;
&#xD;
          -  Subject has a history of self-injurious behavior.&#xD;
&#xD;
          -  Subject has a lifetime history of a clinical diagnosis of major depression or&#xD;
             treatment for major depressive disorder.&#xD;
&#xD;
          -  Subject has a history of clinical diagnosis of borderline personality disorder.&#xD;
&#xD;
          -  Subject has a history of, or is currently presenting with, substance use disorder as&#xD;
             defined by the 5th Edition of the Diagnostic and Statistical Manual (DSM-5).&#xD;
&#xD;
          -  Subject has a history of psychiatric disorders, including a lifetime history of major&#xD;
             depressive disorder, bipolar disorder, panic disorder, generalized anxiety, psychotic&#xD;
             disorders, suicidality or suicidal ideation, or post-traumatic stress disorder.&#xD;
&#xD;
          -  Subject has a history of hypertension and is not on a stable dose of antihypertensive&#xD;
             medications for at least 30 days prior to screening.&#xD;
&#xD;
          -  Subject is currently taking MAOIs, thioridazine, or pimozide.&#xD;
&#xD;
          -  Subject is currently taking tamoxifen, other selective estrogen receptor modulators,&#xD;
             or other hormone deprivation therapy.&#xD;
&#xD;
          -  Subject exhibits evidence of impaired liver function upon entry into the study (values&#xD;
             ≥2 times the upper limit of normal for aspartate transaminase and/or alanine&#xD;
             transaminase, or serum bilirubin ≥1.3 mg/dL) or, in the Investigator's opinion,&#xD;
             exhibits liver function impairment to the extent that the subject should not&#xD;
             participate in the study.&#xD;
&#xD;
          -  Subject has clinically unstable cardiac disease, including unstable atrial&#xD;
             fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active&#xD;
             myocardial ischemia.&#xD;
&#xD;
          -  Subject exhibits evidence of impaired kidney function upon entry into the study (i.e.,&#xD;
             serum creatinine &gt;1.5 mg/dL) or known renal stricture.&#xD;
&#xD;
          -  Subject has biliary tract disease, adrenal cortical insufficiency, or any other&#xD;
             medical condition that, in the Investigator's opinion, is inadequately treated and&#xD;
             precludes entry into the study.&#xD;
&#xD;
          -  Subject has thyroid disease, unless subject is clinically stable with normal thyroid&#xD;
             indices and is on maintenance thyroid medication (e.g., levothyroxine or liothyronine)&#xD;
             for ≥6 months prior to screening.&#xD;
&#xD;
          -  Subject exhibits a positive urine pregnancy test result at screening or at any time&#xD;
             during study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George Raad</last_name>
    <role>Study Director</role>
    <affiliation>PMG Research of Charlotte, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PMG Research of Christie Clinic, LLC</name>
      <address>
        <city>Champaign</city>
        <state>Illinois</state>
        <zip>61820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Cary, LLC</name>
      <address>
        <city>Cary</city>
        <state>North Carolina</state>
        <zip>27518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Charlotte, LLC</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Hickory, LLC</name>
      <address>
        <city>Hickory</city>
        <state>North Carolina</state>
        <zip>28601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Raleigh, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nash OB/GYN</name>
      <address>
        <city>Rocky Mount</city>
        <state>North Carolina</state>
        <zip>27804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Salisbury, LLC</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington, LLC</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Winston-Salem, LLC</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Charleston, LLC</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Bristol, LLC</name>
      <address>
        <city>Bristol</city>
        <state>Tennessee</state>
        <zip>37620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Knoxville</name>
      <address>
        <city>Oak Ridge</city>
        <state>Tennessee</state>
        <zip>37830</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>October 31, 2018</last_update_submitted>
  <last_update_submitted_qc>October 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hot Flashes, vasomotor symptoms, postmenopausal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hot Flashes</mesh_term>
  </condition_browse>
  <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/NCT03285672
org study id: FERV001
nct id: NCT03285672
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to determine the efficacy of FP-101 versus placebo for the
      treatment of hot flashes in postmenopausal women.
Vasomotor symptoms, commonly known as hot flashes or hot flushes, are the most common
      symptoms experienced by women who are perimenopausal or postmenopausal. FP-101 is postulated
      to mediate one of the mechanisms thought to drive hot flashes in post-menopausal women. This
      study will evaluate the efficacy and safety of FP-101 for the treatment of hot flashes in
      post-menopausal women.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The primary efficacy endpoint for the main study is the change in the frequency of moderate-to-severe hot flashes.
time frame: Baseline to Week 8
measure: Change in the severity of moderate-to-severe hot flashes.
time frame: Baseline to Week 8
measure: Change in the severity of moderate-to-severe hot flashes.
time frame: Baseline to Week 4
measure: Change in the frequency of moderate-to-severe hot flashes.
time frame: Baseline to Week 4
arm group label: Arm 1
arm group type: Experimental
description: FP-101
arm group label: Arm 2
arm group type: Placebo Comparator
description: Placebo Comparator
intervention type: Drug
intervention name: FP-101
description: Dose 1
arm group label: Arm 1
intervention type: Drug
intervention name: Placebo Comparator
description: Dose 1
arm group label: Arm 2
criteria: 
gender: Female
gender based: Yes
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: George Raad
role: Study Director
affiliation: PMG Research of Charlotte, LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hot Flashes
sharing ipd: No