Back to resultsGabapentin for the Treatment of Hot Flashes in Menopausal Women
Primary Purpose
Hot Flashes, Menopause
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes focused on measuring gabapentin, hot flashes or flushes, menopause
Eligibility 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.
Sites / Locations
- The Scarborough Hospital
Outcomes
Primary Outcome Measures
Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00112138
First Posted
May 27, 2005
Last Updated
May 20, 2011
Sponsor
North Toronto Primary Care Research Network
1. Study Identification
Unique Protocol Identification Number
NCT00112138
Brief Title
Gabapentin for the Treatment of Hot Flashes in Menopausal Women
Official Title
Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
North Toronto Primary Care Research Network
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Menopause
Keywords
gabapentin, hot flashes or flushes, menopause
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gabapentin
Primary Outcome Measure Information:
Title
Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women
Secondary Outcome Measure Information:
Title
The toxicity profile of gabapentin in this population compared with placebo
Title
The impact of gabapentin on quality of life in this population compared with placebo
Title
Correlation of the Menopause-specific Quality of Life (MENQOL) results with the change in hot flash scores
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Butt, MSc MD CCFP
Organizational Affiliation
North Toronto Primary Care Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Scarborough Hospital
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P 2V5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
12576259
Citation
Guttuso T Jr, Kurlan R, McDermott MP, Kieburtz K. Gabapentin's effects on hot flashes in postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2003 Feb;101(2):337-45. doi: 10.1016/s0029-7844(02)02712-6.
Results Reference
background
Learn more about this trial
Gabapentin for the Treatment of Hot Flashes in Menopausal Women
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