Gabapentin for the Treatment of Hot Flashes in Menopausal Women
Information source: North Toronto Primary Care Research Network
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hot Flashes; Menopause
Intervention: gabapentin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: North Toronto Primary Care Research Network Official(s) and/or principal investigator(s): Debra Butt, MSc MD CCFP, Principal Investigator, Affiliation: North Toronto Primary Care Research Network
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.
Clinical Details
Official title: Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women: A Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women
Secondary outcome: The toxicity profile of gabapentin in this population compared with placeboThe 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
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
Minimum age: 45 Years.
Maximum age: 65 Years.
Gender(s): Female.
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.
Locations and Contacts
The Scarborough Hospital, Scarborough, Ontario M1P 2V5, Canada
Additional Information
Related 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.
Starting date: March 2004
Last updated: May 20, 2011
|