<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/NCT02202707</url>
  </required_header>
  <id_info>
    <org_study_id>2013P002024</org_study_id>
    <nct_id>NCT02202707</nct_id>
  </id_info>
  <brief_title>Vasomotor Symptoms and Cardiovascular Control</brief_title>
  <official_title>Vasomotor Symptoms and Cardiovascular Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Spaulding Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to preliminarily determine whether the frequency and/or severity&#xD;
      of vasomotor symptoms (VMS) at baseline, and then after symptom reduction with gabapentin,&#xD;
      relates to various cardiovascular control measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Visit 1: Screening &amp; Acclimation Visit&#xD;
&#xD;
      The informed consent process for the study will be completed and a signed informed consent&#xD;
      form will be obtained at Spaulding Hospital Cambridge. Subjects will be screened to ensure&#xD;
      they meet preliminary eligibility criteria. All subjects will undergo a clinical interview to&#xD;
      determine the presence of any medical disorders. The following study assessments will be&#xD;
      completed:&#xD;
&#xD;
        -  12-lead EKG&#xD;
&#xD;
        -  Resting blood pressure and heart rate&#xD;
&#xD;
        -  Height and Weight&#xD;
&#xD;
      Visit 2: VMS Determination and At-Home Assessments Subjects will be interviewed about their&#xD;
      mental health history, and will complete questionnaires about their VMS, related&#xD;
      quality-of-life symptoms (sleep, mood) and quality-of-life. Blood will be drawn to confirm&#xD;
      eligibility and to assess for diabetes and chronic kidney disease (see exclusion criteria).&#xD;
      Subjects will be given a 7-day VMS Diary and a 7-day Sleep Diary at the end of this visit, to&#xD;
      be completed at home during the following week. Participants will also be given an&#xD;
      actigraphic watch to take home to wear for 7 days in order to capture sleep/wake patterns and&#xD;
      activity levels for exploratory analyses. During the 7 days of at-home VMS and sleep&#xD;
      monitoring, subjects will also wear a portable VMS monitor for 24 hours to measure objective&#xD;
      VMS frequency.&#xD;
&#xD;
      Visit 3: Final Eligibility Determination &amp; Lab VMS Monitoring Subjects will return the&#xD;
      objective VMS monitor and the VMS and sleep diaries, and the results of their blood tests&#xD;
      taken during the Visit 2 will be reviewed to ensure eligibility. Eligible subjects will&#xD;
      participate in a 6-hour laboratory objective VMS monitoring session by wearing an objective&#xD;
      VMS monitor while simultaneously subjectively monitoring VMS experienced with a written diary&#xD;
      and an event marker. Objective VMS measures obtained during this visit will be the primary&#xD;
      baseline measure of VMS for investigation. Those who have at least 2 objective VMS measured&#xD;
      during the 6-hour monitoring period will be deemed eligible and referred for baseline studies&#xD;
      and to start medication. Participants will be given additional VMS and sleep diaries to&#xD;
      complete on a daily basis throughout the rest of the study period.&#xD;
&#xD;
      Visit 4: Laboratory Testing Visit &amp; Medication Distribution All studies will be performed&#xD;
      between ~8-10 am and will occur at the same time for the second laboratory testing visit. All&#xD;
      subjects will be instructed to abstain from vigorous exercise for 2 days prior to each study&#xD;
      to avoid autonomic and neuroendocrine effects of exercise. In addition, subjects will refrain&#xD;
      from caffeine and alcohol for the previous 24 hrs, and be studied after a 12 hr fast.&#xD;
&#xD;
      A. Study Visit: Parameters to be Measured&#xD;
&#xD;
        1. Electrocardiogram.&#xD;
&#xD;
        2. Arterial Pressure.&#xD;
&#xD;
        3. Respiration.&#xD;
&#xD;
        4. Sympathetic Microneurography.&#xD;
&#xD;
        5. Beat-by-Beat Leg Blood Flow. B. Drugs to Study Human Physiology&#xD;
&#xD;
      1) Intravenous bolus injection of 100 ug nitroprusside bolus (a vasodilator which drops&#xD;
      pressure) 2) Intravenous bolus injection 150 ug phenylephrine bolus (a vasoconstrictor which&#xD;
      raises pressure).&#xD;
&#xD;
      These two drugs are used to drop and raise pressure through a range of arterial pressures&#xD;
      within a very short time, approximately 2 minutes.&#xD;
&#xD;
      These medications raise and lower blood pressure by the same amount typically experienced&#xD;
      during the day when performing activities such as climbing stairs or moving from sitting to&#xD;
      standing.&#xD;
&#xD;
      C. Data to be collected/Timing of collection The study visit will take about 4 hours.&#xD;
      Throughout the protocol, subjects will lie supine and will be instrumented for measurement of&#xD;
      the ECG, beat-by-beat arterial pressure, brachial arterial pressure, respiratory excursions,&#xD;
      and popliteal blood flow velocity. After instrumentation and calibration, instrumentation for&#xD;
      measurement of peroneal nerve muscle sympathetic activity will commence, with the internal&#xD;
      search lasting a maximum of 60 minutes.&#xD;
&#xD;
      After either successful or unsuccessful procurement of the nerve recording, the testing&#xD;
      protocol will start:&#xD;
&#xD;
      Testing Protocol&#xD;
&#xD;
        1. Baseline recordings/measurement (~10 minutes): Subjects will rest quietly for 10&#xD;
           minutes.&#xD;
&#xD;
        2. Modified Oxford Baroreflex tests (5 minutes/trial, 2 trials, ~30 minutes total): An&#xD;
           intravenous bolus injection of 100 ug nitroprusside bolus, followed in 1 minute by a 150&#xD;
           ug phenylephrine bolus. After the first trial, a second modified Oxford baroreflex test&#xD;
           will be performed. At least 10-15 minutes will be allowed between the baroreflex trials&#xD;
           to insure that heart rate, blood pressure and nerve activity return to resting levels.&#xD;
           Subjects will be continually assessed for adverse events and symptoms related to&#xD;
           hypotension.&#xD;
&#xD;
        3. Sustained isometric handgrip exercise (~10 minutes): Subjects will be asked to perform&#xD;
           an isometric handgrip exercise at 30% of maximum effort sustained to fatigue.&#xD;
&#xD;
        4. Valsalva's maneuver (~5 minutes): Subjects will be asked to blow into a tube via a&#xD;
           mouthpiece and generate a pressure of ~40 mmHg sustained for 12 seconds. Data will be&#xD;
           collected for one minute prior to the maneuver, one minute after, with two minutes of&#xD;
           recovery between trials. This will be repeated to obtain three successful trials.&#xD;
&#xD;
        5. Paced breathing (~15 minutes total): Subjects will be asked to maintain a constant&#xD;
           breathing frequency of 15 breaths/min (0.25 Hz) following an audio signal (i.e., &quot;in,&#xD;
           two, out, two&quot;) for 5 minutes after a short period of acclimation.&#xD;
&#xD;
      Distribution of Study Medication: After all baseline measures are complete, study medication&#xD;
      (gabapentin) will be distributed to all study participants and participants will be&#xD;
      instructed as to how to take and titrate the medication dose.&#xD;
&#xD;
      Visit 5a: Medication Dosage &amp; Adverse Event Monitoring (Telephone) Study staff will check in&#xD;
      with study participants over the telephone after they have been on gabapentin for&#xD;
      approximately one week to monitor any side effects or adverse events of the medication. If&#xD;
      subjects are experiencing intolerable side effects, they will be taken off of the medication&#xD;
      while completing the remaining study procedures. In order to track potential after effects of&#xD;
      microneurography, subjects who had the electrode placed beneath the surface of their skin&#xD;
      will be given the Microneurography Questionnaire (MSNA). Over the last 18 years of performing&#xD;
      the technique, roughly 5% of participants have after effects, and of these the most often&#xD;
      reported effect (&gt;90%) is slight bruising at the site of insertion.&#xD;
&#xD;
      Visit 5b: Medication Dosage &amp; Adverse Event Monitoring (Telephone) Study staff will check in&#xD;
      with study participants over the telephone after they have been on gabapentin for&#xD;
      approximately three weeks to monitor any side effects or adverse events of the medication. If&#xD;
      subjects are experiencing intolerable side effects, they will be taken off of the medication&#xD;
      while completing the remaining study procedures.&#xD;
&#xD;
      Visit 6: Objective VMS Monitoring All subjects will repeat the 6-hour laboratory objective&#xD;
      VMS monitoring session on gabapentin for post-treatment measures of VMS, as described above&#xD;
      for Visit 3. Participants will also complete the same set of pre-treatment questionnaires&#xD;
      about their VMS, related quality-of-life symptoms (sleep, mood) and quality-of-life. All&#xD;
      subjects will be given the ambulatory VMS monitor to wear for 24 hours at home, to capture&#xD;
      the frequency of VMS in the ambulatory setting as well as the actigraphic watch to wear for a&#xD;
      one-week period. Participants will be reminded to continue to complete their VMS and sleep&#xD;
      diaries.&#xD;
&#xD;
      Visit 7: Laboratory Testing Visit &amp; Medication Collection Procedures performed during Visit 4&#xD;
      will be repeated at Visit 7, to collect data on cardiovascular measures after participants&#xD;
      have been on gabapentin for at least 4 weeks at the full dose. All VMS and sleep diaries, as&#xD;
      well as unused study medication, actigraphic watch, and the objective VMS monitor, will be&#xD;
      returned and collected at this visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No funding obtained to conduct study&#xD;
  </why_stopped>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alterations in cardiovagal tone with treatment of vasomotor symptoms in women</measure>
    <time_frame>5 weeks</time_frame>
    <description>Cardiovagal tone will be assessed using heart rate and blood pressure at rest and in response to pharmacological and physical tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alterations in sympathetic efferent outflow with treatment of vasomotor symptoms</measure>
    <time_frame>5 weeks</time_frame>
    <description>muscle sympathetic nerve activity at rest and in response to pharmacological and physical tasks</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Vasomotor Symptoms</condition>
  <condition>Cardiovascular Health</condition>
  <arm_group>
    <arm_group_label>Gabapentin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Open label single arm study. All participants will receive Gabapentin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>Study medication, gabapentin, will be distributed to all study participants and participants will be instructed as to how to take and titrate the medication dose. Participants will take gabapentin daily for up to six weeks.</description>
    <arm_group_label>Gabapentin</arm_group_label>
    <other_name>Neurontin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women aged 45 to 58 years,&#xD;
&#xD;
          2. Early postmenopausal, defined as a minimum of one year and up to 6 years from final&#xD;
             menstrual period (FMP)&#xD;
&#xD;
          3. Vasomotor symptoms for at least 6 months&#xD;
&#xD;
               -  At least 4/day or 28/week by retrospective report and confirmed on prospective&#xD;
                  monitoring over 2-week period.&#xD;
&#xD;
               -  At least 2 VMS measured objectively on the VMS monitor during the 6-hour VMS&#xD;
                  laboratory monitoring session.&#xD;
&#xD;
          4. Normal to overweight (18.5≤BMI≤35 kg/m2)&#xD;
&#xD;
          5. Sedentary to normally physically active (performing regular aerobic exercise &lt;60&#xD;
             min/week)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypertension (resting pressures ≥140/90 mmHg)&#xD;
&#xD;
          2. Diabetes (verified by plasma hemoglobin A1C level ≥6.5)&#xD;
&#xD;
          3. Cardiovascular disease, including any stenotic valvular heart disease&#xD;
&#xD;
          4. Neurological disease&#xD;
&#xD;
          5. Current depression (per screening procedures)&#xD;
&#xD;
          6. Current or history of suicidal ideation or attempts (within 3 years prior to&#xD;
             enrollment)&#xD;
&#xD;
          7. Lifetime history of bipolar disorder&#xD;
&#xD;
          8. Active cancer (non-melanoma skin cancer allowed)&#xD;
&#xD;
          9. Abnormal resting ECG&#xD;
&#xD;
         10. Recent weight change (&gt;10 lb weight change in last 6 months)&#xD;
&#xD;
         11. Regular tobacco use/current smoking&#xD;
&#xD;
         12. Current use of anti-hypertensives or other medications that could influence any of the&#xD;
             dependent variables&#xD;
&#xD;
         13. Current or previous use (past 2 months) of anti-anxiety, anti-depressant or&#xD;
             antipsychotic medications&#xD;
&#xD;
         14. Current use of vasodilators&#xD;
&#xD;
         15. Current use of stimulants or stimulant-like medications&#xD;
&#xD;
         16. Current use of systemic hormone therapies/medications&#xD;
&#xD;
         17. Current use of non-hormonal treatments for VMS&#xD;
&#xD;
         18. Current use of gabapentin or medications contraindicated to be used in combination&#xD;
             with gabapentin&#xD;
&#xD;
         19. Past intolerance or hypersensitivity to gabapentin&#xD;
&#xD;
         20. History of syncope or vasovagal/carotid sensitivity&#xD;
&#xD;
         21. History of sickle cell anemia&#xD;
&#xD;
         22. Abnormal kidney function: CrCl or GFR &lt;60 ml/min (Cockcroft and Gault equation)&#xD;
&#xD;
         23. Ventricular tachycardia&#xD;
&#xD;
         24. Hyperthyroidism&#xD;
&#xD;
         25. Hypersensitivity to phenylephrine&#xD;
&#xD;
         26. Compensatory hypertension, where the primary hemodynamic lesion is aortic coarctation&#xD;
             or arteriovenous shunting&#xD;
&#xD;
         27. Congenital (Leber's) optic atrophy or tobacco amblyopia&#xD;
&#xD;
         28. Hypersensitivity to nitroprusside&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>58 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J. Andrew Taylor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spaulding Hospital Cambridge</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spaulding Hospital Cambridge</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>August 18, 2015</last_update_submitted>
  <last_update_submitted_qc>August 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Suzanne Bertisch</investigator_full_name>
    <investigator_title>BIDMC Site Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gabapentin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02202707
org study id: 2013P002024
nct id: NCT02202707
lead sponsor: 
collaborator: 
collaborator: 
The purpose of this study is to preliminarily determine whether the frequency and/or severity
      of vasomotor symptoms (VMS) at baseline, and then after symptom reduction with gabapentin,
      relates to various cardiovascular control measures.
Visit 1: Screening & Acclimation Visit

      The informed consent process for the study will be completed and a signed informed consent
      form will be obtained at Spaulding Hospital Cambridge. Subjects will be screened to ensure
      they meet preliminary eligibility criteria. All subjects will undergo a clinical interview to
      determine the presence of any medical disorders. The following study assessments will be
      completed:

        -  12-lead EKG

        -  Resting blood pressure and heart rate

        -  Height and Weight

      Visit 2: VMS Determination and At-Home Assessments Subjects will be interviewed about their
      mental health history, and will complete questionnaires about their VMS, related
      quality-of-life symptoms (sleep, mood) and quality-of-life. Blood will be drawn to confirm
      eligibility and to assess for diabetes and chronic kidney disease (see exclusion criteria).
      Subjects will be given a 7-day VMS Diary and a 7-day Sleep Diary at the end of this visit, to
      be completed at home during the following week. Participants will also be given an
      actigraphic watch to take home to wear for 7 days in order to capture sleep/wake patterns and
      activity levels for exploratory analyses. During the 7 days of at-home VMS and sleep
      monitoring, subjects will also wear a portable VMS monitor for 24 hours to measure objective
      VMS frequency.

      Visit 3: Final Eligibility Determination & Lab VMS Monitoring Subjects will return the
      objective VMS monitor and the VMS and sleep diaries, and the results of their blood tests
      taken during the Visit 2 will be reviewed to ensure eligibility. Eligible subjects will
      participate in a 6-hour laboratory objective VMS monitoring session by wearing an objective
      VMS monitor while simultaneously subjectively monitoring VMS experienced with a written diary
      and an event marker. Objective VMS measures obtained during this visit will be the primary
      baseline measure of VMS for investigation. Those who have at least 2 objective VMS measured
      during the 6-hour monitoring period will be deemed eligible and referred for baseline studies
      and to start medication. Participants will be given additional VMS and sleep diaries to
      complete on a daily basis throughout the rest of the study period.

      Visit 4: Laboratory Testing Visit & Medication Distribution All studies will be performed
      between ~8-10 am and will occur at the same time for the second laboratory testing visit. All
      subjects will be instructed to abstain from vigorous exercise for 2 days prior to each study
      to avoid autonomic and neuroendocrine effects of exercise. In addition, subjects will refrain
      from caffeine and alcohol for the previous 24 hrs, and be studied after a 12 hr fast.

      A. Study Visit: Parameters to be Measured

        1. Electrocardiogram.

        2. Arterial Pressure.

        3. Respiration.

        4. Sympathetic Microneurography.

        5. Beat-by-Beat Leg Blood Flow. B. Drugs to Study Human Physiology

      1) Intravenous bolus injection of 100 ug nitroprusside bolus (a vasodilator which drops
      pressure) 2) Intravenous bolus injection 150 ug phenylephrine bolus (a vasoconstrictor which
      raises pressure).

      These two drugs are used to drop and raise pressure through a range of arterial pressures
      within a very short time, approximately 2 minutes.

      These medications raise and lower blood pressure by the same amount typically experienced
      during the day when performing activities such as climbing stairs or moving from sitting to
      standing.

      C. Data to be collected/Timing of collection The study visit will take about 4 hours.
      Throughout the protocol, subjects will lie supine and will be instrumented for measurement of
      the ECG, beat-by-beat arterial pressure, brachial arterial pressure, respiratory excursions,
      and popliteal blood flow velocity. After instrumentation and calibration, instrumentation for
      measurement of peroneal nerve muscle sympathetic activity will commence, with the internal
      search lasting a maximum of 60 minutes.

      After either successful or unsuccessful procurement of the nerve recording, the testing
      protocol will start:

      Testing Protocol

        1. Baseline recordings/measurement (~10 minutes): Subjects will rest quietly for 10
           minutes.

        2. Modified Oxford Baroreflex tests (5 minutes/trial, 2 trials, ~30 minutes total): An
           intravenous bolus injection of 100 ug nitroprusside bolus, followed in 1 minute by a 150
           ug phenylephrine bolus. After the first trial, a second modified Oxford baroreflex test
           will be performed. At least 10-15 minutes will be allowed between the baroreflex trials
           to insure that heart rate, blood pressure and nerve activity return to resting levels.
           Subjects will be continually assessed for adverse events and symptoms related to
           hypotension.

        3. Sustained isometric handgrip exercise (~10 minutes): Subjects will be asked to perform
           an isometric handgrip exercise at 30% of maximum effort sustained to fatigue.

        4. Valsalva's maneuver (~5 minutes): Subjects will be asked to blow into a tube via a
           mouthpiece and generate a pressure of ~40 mmHg sustained for 12 seconds. Data will be
           collected for one minute prior to the maneuver, one minute after, with two minutes of
           recovery between trials. This will be repeated to obtain three successful trials.

        5. Paced breathing (~15 minutes total): Subjects will be asked to maintain a constant
           breathing frequency of 15 breaths/min (0.25 Hz) following an audio signal (i.e., "in,
           two, out, two") for 5 minutes after a short period of acclimation.

      Distribution of Study Medication: After all baseline measures are complete, study medication
      (gabapentin) will be distributed to all study participants and participants will be
      instructed as to how to take and titrate the medication dose.

      Visit 5a: Medication Dosage & Adverse Event Monitoring (Telephone) Study staff will check in
      with study participants over the telephone after they have been on gabapentin for
      approximately one week to monitor any side effects or adverse events of the medication. If
      subjects are experiencing intolerable side effects, they will be taken off of the medication
      while completing the remaining study procedures. In order to track potential after effects of
      microneurography, subjects who had the electrode placed beneath the surface of their skin
      will be given the Microneurography Questionnaire (MSNA). Over the last 18 years of performing
      the technique, roughly 5% of participants have after effects, and of these the most often
      reported effect (>90%) is slight bruising at the site of insertion.

      Visit 5b: Medication Dosage & Adverse Event Monitoring (Telephone) Study staff will check in
      with study participants over the telephone after they have been on gabapentin for
      approximately three weeks to monitor any side effects or adverse events of the medication. If
      subjects are experiencing intolerable side effects, they will be taken off of the medication
      while completing the remaining study procedures.

      Visit 6: Objective VMS Monitoring All subjects will repeat the 6-hour laboratory objective
      VMS monitoring session on gabapentin for post-treatment measures of VMS, as described above
      for Visit 3. Participants will also complete the same set of pre-treatment questionnaires
      about their VMS, related quality-of-life symptoms (sleep, mood) and quality-of-life. All
      subjects will be given the ambulatory VMS monitor to wear for 24 hours at home, to capture
      the frequency of VMS in the ambulatory setting as well as the actigraphic watch to wear for a
      one-week period. Participants will be reminded to continue to complete their VMS and sleep
      diaries.

      Visit 7: Laboratory Testing Visit & Medication Collection Procedures performed during Visit 4
      will be repeated at Visit 7, to collect data on cardiovascular measures after participants
      have been on gabapentin for at least 4 weeks at the full dose. All VMS and sleep diaries, as
      well as unused study medication, actigraphic watch, and the objective VMS monitor, will be
      returned and collected at this visit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Alterations in cardiovagal tone with treatment of vasomotor symptoms in women
time frame: 5 weeks
description: Cardiovagal tone will be assessed using heart rate and blood pressure at rest and in response to pharmacological and physical tasks
measure: Alterations in sympathetic efferent outflow with treatment of vasomotor symptoms
time frame: 5 weeks
description: muscle sympathetic nerve activity at rest and in response to pharmacological and physical tasks
arm group label: Gabapentin
arm group type: Other
description: Open label single arm study. All participants will receive Gabapentin.
intervention type: Drug
intervention name: Gabapentin
description: Study medication, gabapentin, will be distributed to all study participants and participants will be instructed as to how to take and titrate the medication dose. Participants will take gabapentin daily for up to six weeks.
arm group label: Gabapentin
other name: Neurontin
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 58 Years
healthy volunteers: Accepts Healthy Volunteers
last name: J. Andrew Taylor, PhD
role: Principal Investigator
affiliation: Spaulding Hospital Cambridge
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Suzanne Bertisch
investigator title: BIDMC Site Investigator
mesh term: Gabapentin