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OpenTrials
Completed

NCT Number: NCT00112138

Gabapentin for the Treatment of Hot Flashes in Menopausal Women

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.

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

The Scarborough Hospital

Scarborough Village, Ontario, M1P 2V5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gabapentin

Drug

Primary outcomes

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

Secondary outcomes

  1. The toxicity profile of gabapentin in this population compared with placebo

  2. The impact of gabapentin on quality of life in this population compared with placebo

  3. Correlation of the Menopause-specific Quality of Life (MENQOL) results with the change in hot flash scores

Sponsors and collaborators

Lead sponsor

North Toronto Primary Care Research Network

Network

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
May 30, 2005
Registry last updated
May 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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