Gabapentin for the Treatment of Hot Flashes in Menopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hot Flashes, Menopause

Intervention / Treatment
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* Drug: gabapentin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gabapentin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gabapentin, hot flashes or flushes, menopause