Vasomotor Symptoms and Cardiovascular Control

• Status: Withdrawn
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Brigham and Women's Hospital; Spaulding Rehabilitation Hospital
• Treatments: Gabapentin; gamma-Aminobutyric Acid

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