Vasomotor Symptoms and Cardiovascular Control
Withdrawn before enrolling · Not applicable
Conditions studied: Vasomotor Symptoms, Cardiovascular Health
In brief
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.
Key facts
- Study ID
- NCT02202707
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 0
- Starts
- 2014-05-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2015-08-19
Who can join
Age: 45 and older, up to 58. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Spaulding Hospital Cambridge — Cambridge, Massachusetts, United States
Full record on ClinicalTrials.gov
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