Gabapentin for the Treatment of Hot Flashes in Menopausal Women | RxWiki

Gabapentin for the Treatment of Hot Flashes in Menopausal Women

Overview[ - collapse ][ - ]

Purpose	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	Hot Flashes Menopause
Intervention	Drug: gabapentin
Phase	Phase 3
Sponsor	North Toronto Primary Care Research Network
Responsible Party	North Toronto Primary Care Research Network
ClinicalTrials.gov Identifier	NCT00112138
First Received	May 27, 2005
Last Updated	May 20, 2011
Last verified	May 2011

Tracking Information[ + expand ][ + ]

First Received Date	May 27, 2005
Last Updated Date	May 20, 2011
Start Date	March 2004
Estimated Primary Completion Date	February 2006
Current Primary Outcome Measures	Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women
Current 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

Descriptive Information[ + expand ][ + ]

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
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.
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Condition	Hot Flashes Menopause
Intervention	Drug: gabapentin
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	200
Estimated Completion Date	February 2006
Estimated Primary Completion Date	Not Provided
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.
Gender	Female
Ages	45 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Canada

Administrative Information[ + expand ][ + ]

NCT Number	NCT00112138
Other Study ID Numbers	03-19
Has Data Monitoring Committee	Not Provided
Information Provided By	North Toronto Primary Care Research Network
Study Sponsor	North Toronto Primary Care Research Network
Collaborators	Not Provided
Investigators	Principal Investigator: Debra Butt, MSc MD CCFP North Toronto Primary Care Research Network
Verification Date	May 2011

Locations[ + expand ][ + ]