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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.
ClinicalTrials.gov Identifier: NCT00112138
Recruitment Status : Completed
First Posted : May 30, 2005
Last Update Posted : May 23, 2011
Sponsor:
Information provided by:

Study Description
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00112138


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

Publications:
ClinicalTrials.gov Identifier: NCT00112138     History of Changes
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:
gabapentin
hot flashes or flushes
menopause

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents