xml: <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/NCT05971849</url>
    </required_header>
    <id_info>
      <org_study_id>2023P001356</org_study_id>
      <nct_id>NCT05971849</nct_id>
    </id_info>
    <brief_title>Dampening the Reproductive Axis With Continuous Kisspeptin</brief_title>
    <official_title>Dampening the Reproductive Axis With Continuous Kisspeptin</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stephanie B. Seminara, MD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts General Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this study is to assess response to kisspeptin as well as the baseline patterns&#xD;
        of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Assignment: All study subjects will undergo the same interventions. Baseline LH secretion&#xD;
        patterns of individuals with PCOS will be compared to their LH secretion patterns while&#xD;
        receiving a kisspeptin infusion.&#xD;
  &#xD;
        Delivery of Interventions:&#xD;
  &#xD;
          -  Prior to the inpatient study visit, the subjects will undergo a review of their medical&#xD;
             history, physical exam, and screening laboratories.&#xD;
  &#xD;
          -  On the day of the study, the subjects will have an intravenous (IV) line placed and&#xD;
  &#xD;
               -  Undergo up to q10 min blood sampling x 36 hours&#xD;
  &#xD;
               -  Receive an infusion of kisspeptin x 24 hours&#xD;
  &#xD;
               -  Receive up to two kisspeptin IV boluses&#xD;
  &#xD;
               -  Receive up to one gonadotropin-releasing hormone (GnRH) IV bolus&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 31, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Average change in LH pulse frequency</measure>
      <time_frame>6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion</time_frame>
      <description>Average change in LH pulse frequency before and during kisspeptin infusion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Average change in LH pulse amplitude</measure>
      <time_frame>6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion</time_frame>
      <description>Average change in LH pulse amplitude before and during kisspeptin infusion</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">26</enrollment>
    <condition>Reproductive Disorder</condition>
    <condition>PCOS</condition>
    <condition>Polycystic Ovary Syndrome</condition>
    <arm_group>
      <arm_group_label>kisspeptin, GnRH</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>IV administration of kisspeptin 112-121; 24-hour infusion. IV administration of GnRH; up to one bolus.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>kisspeptin 112-121</intervention_name>
      <description>IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin</description>
      <arm_group_label>kisspeptin, GnRH</arm_group_label>
      <other_name>metastin 45-54</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GnRH</intervention_name>
      <description>Up to one IV bolus of GnRH</description>
      <arm_group_label>kisspeptin, GnRH</arm_group_label>
      <other_name>gonadotropin-releasing hormone</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          -  Ages 18-45 years&#xD;
  &#xD;
            -  A history of clinical diagnosis of PCOS or equivalent clinical features&#xD;
  &#xD;
            -  BMI &gt;18.5 and &lt;35 kg/m2&#xD;
  &#xD;
            -  Normal blood pressure (systolic BP &lt; 140 mm Hg, diastolic &gt; 90 mm Hg)&#xD;
  &#xD;
            -  Laboratory studies:&#xD;
  &#xD;
                 -  Negative human chorionic gonadotropin (hCG) pregnancy test prior to kisspeptin&#xD;
                    administration&#xD;
  &#xD;
                 -  Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for&#xD;
                    healthy women&#xD;
  &#xD;
            -  Not using hormonal medication or willing to complete an appropriate washout for that&#xD;
               particular medication and its method of administration&#xD;
  &#xD;
            -  No current or recent use of a medication that, in the opinion of a study investigator,&#xD;
               can modulate the reproductive axis or willing to complete an appropriate washout for&#xD;
               that particular medication and its method of administration&#xD;
  &#xD;
            -  No history of a medication reaction that required emergency medical care&#xD;
  &#xD;
            -  No excessive alcohol consumption (&gt;10 drinks/week) and/or ongoing use of illicit drugs&#xD;
  &#xD;
               • Any current use of marijuana will be evaluated by a study medical professional to&#xD;
               determine if it is expected to impact study participation&#xD;
  &#xD;
            -  Not pregnant or trying to become pregnant&#xD;
  &#xD;
            -  Not breastfeeding&#xD;
  &#xD;
            -  No history of bilateral oophorectomy (both ovaries removed)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stephanie B Seminara, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Coordinator</last_name>
      <phone>617-643-2308</phone>
      <email>MGHKisspeptinResearch@partners.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Massachusetts General Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Study Coordinator</last_name>
        <phone>617-643-2308</phone>
        <email>MGHKisspeptinResearch@partners.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Stephanie B. Seminara, MD</investigator_full_name>
      <investigator_title>Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine</investigator_title>
    </responsible_party>
    <keyword>reproductive disorders</keyword>
    <keyword>kisspeptin</keyword>
    <keyword>PCOS</keyword>
    <keyword>GnRH</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hormones</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971849
  org study id: 2023P001356
  nct id: NCT05971849
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this study is to assess response to kisspeptin as well as the baseline patterns
        of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).
  Assignment: All study subjects will undergo the same interventions. Baseline LH secretion
        patterns of individuals with PCOS will be compared to their LH secretion patterns while
        receiving a kisspeptin infusion.
  
        Delivery of Interventions:
  
          -  Prior to the inpatient study visit, the subjects will undergo a review of their medical
             history, physical exam, and screening laboratories.
  
          -  On the day of the study, the subjects will have an intravenous (IV) line placed and
  
               -  Undergo up to q10 min blood sampling x 36 hours
  
               -  Receive an infusion of kisspeptin x 24 hours
  
               -  Receive up to two kisspeptin IV boluses
  
               -  Receive up to one gonadotropin-releasing hormone (GnRH) IV bolus
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Average change in LH pulse frequency
  time frame: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
  description: Average change in LH pulse frequency before and during kisspeptin infusion
  measure: Average change in LH pulse amplitude
  time frame: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
  description: Average change in LH pulse amplitude before and during kisspeptin infusion
  arm group label: kisspeptin, GnRH
  arm group type: Experimental
  description: IV administration of kisspeptin 112-121; 24-hour infusion. IV administration of GnRH; up to one bolus.
  intervention type: Drug
  intervention name: kisspeptin 112-121
  description: IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin
  arm group label: kisspeptin, GnRH
  other name: metastin 45-54
  intervention type: Drug
  intervention name: GnRH
  description: Up to one IV bolus of GnRH
  arm group label: kisspeptin, GnRH
  other name: gonadotropin-releasing hormone
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Stephanie B Seminara, MD
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  last name: Study Coordinator
  phone: 617-643-2308
  email: MGHKisspeptinResearch@partners.org
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Stephanie B. Seminara, MD
  investigator title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine
  mesh term: Polycystic Ovary Syndrome
  mesh term: Hormones
  sharing ipd: No