Gabapentin for the Treatment of Hot Flashes in Menopausal Women

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: North Toronto Primary Care Research Network
• Treatments: Gabapentin; gamma-Aminobutyric Acid

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.