NCT02202707

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

2.1 years

First QC Date

July 22, 2014

Last Update Submit

August 18, 2015

Conditions

Vasomotor SymptomsCardiovascular Health

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Gabapentin

OTHER

Open label single arm study. All participants will receive Gabapentin.

Drug: Gabapentin

Interventions

GabapentinDRUG

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.

Also known as: Neurontin
Gabapentin

Eligibility Criteria

Age45 Years - 58 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Spaulding Hospital Cambridge

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • J. Andrew Taylor, PhD

    Spaulding Hospital Cambridge

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BIDMC Site Investigator

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 29, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

US(2)