Gabapentin for the Treatment of Hot Flashes in Menopausal Women
Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women: A Randomized Controlled Trial
2 other identifiers
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 27, 2005
CompletedFirst Posted
Study publicly available on registry
May 30, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedMay 23, 2011
May 1, 2011
May 27, 2005
May 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Scarborough Hospital
Scarborough Village, Ontario, M1P 2V5, Canada
Related Publications (1)
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.
PMID: 12576259BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Debra Butt, MSc MD CCFP
North Toronto Primary Care Research Network
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
May 27, 2005
First Posted
May 30, 2005
Study Start
March 1, 2004
Study Completion
February 1, 2006
Last Updated
May 23, 2011
Record last verified: 2011-05