Gabapentin for the Treatment of Hot Flashes in Menopausal Women

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00112138
Study type	Interventional
Source	North Toronto Primary Care Research Network
Contact
Status	Completed
Phase	Phase 3
Start date	March 2004
Completion date	February 2006

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