Clinical Trial: Gabapentin for the Treatment of Hot Flashes in Menopausal Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary: 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.
Sponsor: North Toronto Primary Care Research Network

Current Primary Outcome: Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: North Toronto Primary Care Research Network

Dates:
Date Received: May 27, 2005
Date Started: March 2004
Date Completion: February 2006
Last Updated: May 20, 2011
Last Verified: May 2011