Vasomotor Symptoms Clinical Trial
Official title:
Vasomotor Symptoms and Cardiovascular Control
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years to 58 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Spaulding Hospital Cambridge | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Brigham and Women's Hospital, Spaulding Rehabilitation Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alterations in cardiovagal tone with treatment of vasomotor symptoms in women | Cardiovagal tone will be assessed using heart rate and blood pressure at rest and in response to pharmacological and physical tasks | 5 weeks | No |
Primary | Alterations in sympathetic efferent outflow with treatment of vasomotor symptoms | muscle sympathetic nerve activity at rest and in response to pharmacological and physical tasks | 5 weeks | No |
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