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Vasomotor Symptoms and Cardiovascular Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202707
Recruitment Status : Withdrawn (No funding obtained to conduct study)
First Posted : July 29, 2014
Last Update Posted : August 19, 2015
Sponsor:
Collaborators:
Brigham and Women's Hospital
Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):
Suzanne Bertisch, Beth Israel Deaconess Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vasomotor Symptoms Cardiovascular Health Drug: Gabapentin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vasomotor Symptoms and Cardiovascular Control
Study Start Date : May 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Gabapentin
Open label single arm study. All participants will receive Gabapentin.
Drug: Gabapentin
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.
Other Name: Neurontin




Primary Outcome Measures :
  1. Alterations in cardiovagal tone with treatment of vasomotor symptoms in women [ Time Frame: 5 weeks ]
    Cardiovagal tone will be assessed using heart rate and blood pressure at rest and in response to pharmacological and physical tasks

  2. Alterations in sympathetic efferent outflow with treatment of vasomotor symptoms [ Time Frame: 5 weeks ]
    muscle sympathetic nerve activity at rest and in response to pharmacological and physical tasks



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 58 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women aged 45 to 58 years,
  2. Early postmenopausal, defined as a minimum of one year and up to 6 years from final menstrual period (FMP)
  3. Vasomotor symptoms for at least 6 months

    • At least 4/day or 28/week by retrospective report and confirmed on prospective monitoring over 2-week period.
    • At least 2 VMS measured objectively on the VMS monitor during the 6-hour VMS laboratory monitoring session.
  4. Normal to overweight (18.5≤BMI≤35 kg/m2)
  5. Sedentary to normally physically active (performing regular aerobic exercise <60 min/week)

Exclusion Criteria:

  1. Hypertension (resting pressures ≥140/90 mmHg)
  2. Diabetes (verified by plasma hemoglobin A1C level ≥6.5)
  3. Cardiovascular disease, including any stenotic valvular heart disease
  4. Neurological disease
  5. Current depression (per screening procedures)
  6. Current or history of suicidal ideation or attempts (within 3 years prior to enrollment)
  7. Lifetime history of bipolar disorder
  8. Active cancer (non-melanoma skin cancer allowed)
  9. Abnormal resting ECG
  10. Recent weight change (>10 lb weight change in last 6 months)
  11. Regular tobacco use/current smoking
  12. Current use of anti-hypertensives or other medications that could influence any of the dependent variables
  13. Current or previous use (past 2 months) of anti-anxiety, anti-depressant or antipsychotic medications
  14. Current use of vasodilators
  15. Current use of stimulants or stimulant-like medications
  16. Current use of systemic hormone therapies/medications
  17. Current use of non-hormonal treatments for VMS
  18. Current use of gabapentin or medications contraindicated to be used in combination with gabapentin
  19. Past intolerance or hypersensitivity to gabapentin
  20. History of syncope or vasovagal/carotid sensitivity
  21. History of sickle cell anemia
  22. Abnormal kidney function: CrCl or GFR <60 ml/min (Cockcroft and Gault equation)
  23. Ventricular tachycardia
  24. Hyperthyroidism
  25. Hypersensitivity to phenylephrine
  26. Compensatory hypertension, where the primary hemodynamic lesion is aortic coarctation or arteriovenous shunting
  27. Congenital (Leber's) optic atrophy or tobacco amblyopia
  28. Hypersensitivity to nitroprusside

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202707


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Spaulding Hospital Cambridge
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Spaulding Rehabilitation Hospital
Investigators
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Principal Investigator: J. Andrew Taylor, PhD Spaulding Hospital Cambridge
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Responsible Party: Suzanne Bertisch, BIDMC Site Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02202707    
Other Study ID Numbers: 2013P002024
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents