Gabapentin for the Treatment of Hot Flashes in Menopausal Women

NCT ID: NCT00112138

Last Updated: 2011-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2006-02-28

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 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.

Conditions

Hot Flashes; Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

gabapentin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

North Toronto Primary Care Research Network

NETWORK

Sponsor Role: lead

Principal Investigators

Debra Butt, MSc MD CCFP

Role: PRINCIPAL_INVESTIGATOR

North Toronto Primary Care Research Network

Locations

The Scarborough Hospital

Scarborough Village, Ontario, Canada

Countries

Canada

References

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. doi: 10.1016/s0029-7844(02)02712-6.

Reference Type: BACKGROUND

PMID: 12576259 (View on PubMed)

Other Identifiers

Health Canada: CN 082818

Identifier Type: -

Identifier Source: secondary_id

03-19

Identifier Type: -

Identifier Source: org_study_id