Clinical trial NCT00112138: Gabapentin for the Treatment of Hot Flashes in Menopausal Women
Official title: Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hot Flashes
Menopause
Keywords: gabapentin
hot flashes or flushes
menopause
Lead sponsor: North Toronto Primary Care Research Network
Sponsor class: NETWORK
First posted: 2005-05-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women
Secondary outcomes:
measure: The toxicity profile of gabapentin in this population compared with placebo
measure: The impact of gabapentin on quality of life in this population compared with placebo
measure: Correlation of the Menopause-specific Quality of Life (MENQOL) results with the change in hot flash scores
Other outcomes:
Locations:
city: Scarborough
country: Canada
facility: The Scarborough Hospital
state: Ontario
Study officials:
affiliation: North Toronto Primary Care Research Network
name: Debra Butt, MSc MD CCFP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.