Gabapentin for the Treatment of Hot Flashes in Menopausal Women

May 20, 2011 updated by: North Toronto Primary Care Research Network

Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women: A Randomized Controlled Trial

The purpose of this study is to evaluate the effectiveness and safety of gabapentin compared to placebo in the treatment of hot flashes in postmenopausal women using a phase III randomized controlled trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For women who fear developing breast cancer, those who have contraindications to hormone replacement therapy and those who prefer an alternative treatment, there is presently no standard treatment for hot flashes. Women and health care providers have few options other than hormone replacement therapy as evidenced-based trials of alternatives have not shown many effective options. Many non-hormonal agents have been studied including antidepressants, antihypertensives, vitamin E, soy products, black cohosh, acupuncture, and belladonna and ergotamine combinations. Preliminary studies using the antiseizure medication, gabapentin (Neurontin), has demonstrated a substantial reduction in hot flashes. This agent may provide an effective treatment for hot flashes in postmenopausal women.

Study Type

Interventional

Enrollment

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Scarborough, Ontario, Canada, M1P 2V5
        • The Scarborough Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with substantial hot flashes defined as reporting at least 14 hot flashes per week.
  • Postmenopausal women as defined by the natural cessation of menses for 1 year.
  • Aged 45 - 65 years.

Exclusion Criteria:

  • Women on hormone replacement therapy.
  • Women with a surgically induced menopause (oophorectomy).
  • Women on tamoxifen or receiving chemotherapy/radiation therapy or planned antineoplastic chemotherapy/radiation therapy.
  • Renal function impairment (serum creatinine greater than the laboratory normal range; or creatinine clearance <30ml/min).
  • Use of antidepressants with serotonin reuptake mechanisms and antiseizure medications within the past month.
  • Neurologic conditions: seizures, vertigo, and syncope.
  • Known hypersensitivity to gabapentin and its components.
  • Inability to complete questionnaires for any reason including psychiatric disorders.
  • History of a hypothalamic dysfunction.
  • Life expectancy less than 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women

Secondary Outcome Measures

Outcome Measure
The toxicity profile of gabapentin in this population compared with placebo
The impact of gabapentin on quality of life in this population compared with placebo
Correlation of the Menopause-specific Quality of Life (MENQOL) results with the change in hot flash scores

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Toronto Primary Care Research Network

Investigators

  • Principal Investigator: Debra Butt, MSc MD CCFP, North Toronto Primary Care Research Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

May 27, 2005

First Submitted That Met QC Criteria

May 27, 2005

First Posted (Estimate)

May 30, 2005

Study Record Updates

Last Update Posted (Estimate)

May 23, 2011

Last Update Submitted That Met QC Criteria

May 20, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-19
  • Health Canada: CN 082818

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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