Gabapentin for the Treatment of Hot Flashes in Menopausal Women - Tabular View

Tracking Information

First Received Date ^ICMJE

May 27, 2005

Last Updated Date

April 7, 2006

Start Date ^ICMJE

March 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00112138 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Gabapentin for the Treatment of Hot Flashes in Menopausal Women

Official Title ^ICMJE

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hot Flashes
Menopause

Intervention ^ICMJE

Drug: gabapentin

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

200

Completion Date

February 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

45 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00112138

Responsible Party

Study ID Numbers ^ICMJE

03-19, Health Canada: CN 082818

Study Sponsor ^ICMJE

North Toronto Primary Care Research Network

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Debra Butt, MSc MD CCFP

North Toronto Primary Care Research Network

Information Provided By

North Toronto Primary Care Research Network

Verification Date

April 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP