Gabapentin for the Treatment of Hot Flashes in Menopausal Women

Menopause Clinical Trial

Official title:

Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112138
• Other study ID #: 03-19
• Secondary ID: Health Canada: C
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2005
• Last updated: May 20, 2011
• Start date: March 2004
• Est. completion date: February 2006

Study information

• Verified date: May 2011
• Source: North Toronto Primary Care Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

Drug:
• gabapentin

Locations

Country	Name	City	State
Canada	The Scarborough Hospital	Scarborough	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
North Toronto Primary Care Research Network

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women
Secondary	The toxicity profile of gabapentin in this population compared with placebo
Secondary	The impact of gabapentin on quality of life in this population compared with placebo
Secondary	Correlation of the Menopause-specific Quality of Life (MENQOL) results with the change in hot flash scores