Status:
COMPLETED
Gabapentin for the Treatment of Hot Flashes in Menopausal Women
Lead Sponsor:
North Toronto Primary Care Research Network
Conditions:
Hot Flashes
Menopause
Eligibility:
FEMALE
45-65 years
Phase:
PHASE3
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00112138
Start Date
March 1 2004
End Date
February 1 2006
Last Update
May 23 2011
Active Locations (1)
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1
The Scarborough Hospital
Scarborough Village, Ontario, Canada, M1P 2V5