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

Sponsor:	North Toronto Primary Care Research Network
Information provided by:	North Toronto Primary Care Research Network
ClinicalTrials.gov Identifier:	NCT00112138

Purpose

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.

Condition	Intervention	Phase
Hot Flashes Menopause	Drug: gabapentin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by North Toronto Primary Care Research Network:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	March 2004
Estimated Study Completion Date:	February 2006

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.

Eligibility

Ages Eligible for Study:	45 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112138

Locations

Canada, Ontario
The Scarborough Hospital
Scarborough, Ontario, Canada, M1P 2V5

Sponsors and Collaborators

North Toronto Primary Care Research Network

Investigators

Principal Investigator:

Debra Butt, MSc MD CCFP

North Toronto Primary Care Research Network

More Information

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.

ClinicalTrials.gov Identifier:	NCT00112138 History of Changes
Other Study ID Numbers:	03-19, Health Canada: CN 082818
Study First Received:	May 27, 2005
Last Updated:	May 20, 2011
Health Authority:	Canada: Health Canada

Keywords provided by North Toronto Primary Care Research Network:

gabapentin
hot flashes or flushes
menopause

Additional relevant MeSH terms:

Hot Flashes
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents

Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on February 09, 2012