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	Treatment or Intervention	Phase
Hot Flashes Menopause	Drug: gabapentin	Phase III

Further Study Details: 

Primary Outcomes: Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women
Secondary Outcomes: 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
Expected Total Enrollment:  200

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   -   65 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00112138

Debra Butt, MSc MD CCFP      (416) 439-6523    debra.butt@sympatico.ca
Laura Tindall, RN      (416) 431-8200  Ext. 6078    ltindall@tsh.to

Canada, Ontario
      The Scarborough Hospital, Scarborough,  Ontario,  M1P 2T7,  Canada; Recruiting

Study chairs or principal investigators

Debra Butt, MSc MD CCFP,  Principal Investigator,  North Toronto Primary Care Research Network   

Study ID Numbers:  03-19; Health Canada: CN 082818
Record last reviewed:  May 2005
Last Updated:  May 27, 2005
Record first received:  May 27, 2005
ClinicalTrials.gov Identifier:  NCT00112138
Health Authority: Canada: Health Canada (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-31