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Sponsored by: |
North Toronto Primary Care Research Network |
Information provided by: | North Toronto Primary Care Research Network |
ClinicalTrials.gov Identifier: | NCT00112138 |
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 | Intervention | Phase |
Hot Flashes Menopause |
Drug: gabapentin |
Phase III |
MedlinePlus related topics: | Menopause |
ChemIDplus related topics: | Gabapentin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women: A Randomized Controlled Trial |
Estimated Enrollment: | 200 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | February 2006 |
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.
Ages Eligible for Study: | 45 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |||||
The Scarborough Hospital | |||||
Scarborough, Ontario, Canada, M1P 2V5 |
North Toronto Primary Care Research Network |
Principal Investigator: | Debra Butt, MSc MD CCFP | North Toronto Primary Care Research Network |
Study ID Numbers: | 03-19, Health Canada: CN 082818 |
First Received: | May 27, 2005 |
Last Updated: | April 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00112138 |
Health Authority: | Canada: Health Canada |
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