Status:
WITHDRAWN
Vasomotor Symptoms and Cardiovascular Control
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Brigham and Women's Hospital
Spaulding Rehabilitation Hospital
Conditions:
Vasomotor Symptoms
Cardiovascular Health
Eligibility:
FEMALE
45-58 years
Phase:
NA
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 vari...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Women aged 45 to 58 years,
- Early postmenopausal, defined as a minimum of one year and up to 6 years from final menstrual period (FMP)
- 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.
- Normal to overweight (18.5≤BMI≤35 kg/m2)
- Sedentary to normally physically active (performing regular aerobic exercise \<60 min/week)
Exclusion
- Hypertension (resting pressures ≥140/90 mmHg)
- Diabetes (verified by plasma hemoglobin A1C level ≥6.5)
- Cardiovascular disease, including any stenotic valvular heart disease
- Neurological disease
- Current depression (per screening procedures)
- Current or history of suicidal ideation or attempts (within 3 years prior to enrollment)
- Lifetime history of bipolar disorder
- Active cancer (non-melanoma skin cancer allowed)
- Abnormal resting ECG
- Recent weight change (\>10 lb weight change in last 6 months)
- Regular tobacco use/current smoking
- Current use of anti-hypertensives or other medications that could influence any of the dependent variables
- Current or previous use (past 2 months) of anti-anxiety, anti-depressant or antipsychotic medications
- Current use of vasodilators
- Current use of stimulants or stimulant-like medications
- Current use of systemic hormone therapies/medications
- Current use of non-hormonal treatments for VMS
- Current use of gabapentin or medications contraindicated to be used in combination with gabapentin
- Past intolerance or hypersensitivity to gabapentin
- History of syncope or vasovagal/carotid sensitivity
- History of sickle cell anemia
- Abnormal kidney function: CrCl or GFR \<60 ml/min (Cockcroft and Gault equation)
- Ventricular tachycardia
- Hyperthyroidism
- Hypersensitivity to phenylephrine
- Compensatory hypertension, where the primary hemodynamic lesion is aortic coarctation or arteriovenous shunting
- Congenital (Leber's) optic atrophy or tobacco amblyopia
- Hypersensitivity to nitroprusside
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02202707
Start Date
May 1 2014
End Date
June 1 2016
Last Update
August 19 2015
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Spaulding Hospital Cambridge
Cambridge, Massachusetts, United States, 02138