Gabapentin for the Treatment of Hot Flashes in Menopausal Women

North Toronto Primary Care Research Network

Status and phase

Completed

Phase 3

Conditions

Menopause

Hot Flashes

Treatments

Drug: gabapentin

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00112138

Health Canada: CN 082818

03-19

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.