Gabapentin for the Treatment of Hot Flashes in Menopausal Women

This study has been completed.
Sponsor:
Information provided by:
North Toronto Primary Care Research Network
ClinicalTrials.gov Identifier:
NCT00112138
First received: May 27, 2005
Last updated: May 20, 2011
Last verified: May 2011

May 27, 2005
May 20, 2011
March 2004
Not Provided
Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women
Same as current
Complete list of historical versions of study NCT00112138 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Hot Flashes
  • Menopause
Drug: gabapentin
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
February 2006
Not Provided

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Female
45 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00112138
03-19, Health Canada: CN 082818
Not Provided
Not Provided
North Toronto Primary Care Research Network
Not Provided
Principal Investigator: Debra Butt, MSc MD CCFP North Toronto Primary Care Research Network
North Toronto Primary Care Research Network
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP