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Gabapentin for the Treatment of Hot Flashes in Menopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00112138
Recruitment Status : Completed
First Posted : May 30, 2005
Last Update Posted : May 23, 2011
Information provided by:
North Toronto Primary Care Research Network

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hot Flashes Menopause Drug: gabapentin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women: A Randomized Controlled Trial
Study Start Date : March 2004
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Primary Outcome Measures :
  1. Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women

Secondary Outcome Measures :
  1. The toxicity profile of gabapentin in this population compared with placebo
  2. The impact of gabapentin on quality of life in this population compared with placebo
  3. Correlation of the Menopause-specific Quality of Life (MENQOL) results with the change in hot flash scores

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00112138

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Canada, Ontario
The Scarborough Hospital
Scarborough, Ontario, Canada, M1P 2V5
Sponsors and Collaborators
North Toronto Primary Care Research Network
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Principal Investigator: Debra Butt, MSc MD CCFP North Toronto Primary Care Research Network

Layout table for additonal information Identifier: NCT00112138    
Other Study ID Numbers: 03-19
Health Canada: CN 082818
First Posted: May 30, 2005    Key Record Dates
Last Update Posted: May 23, 2011
Last Verified: May 2011
Keywords provided by North Toronto Primary Care Research Network:
hot flashes or flushes
Additional relevant MeSH terms:
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Hot Flashes
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents