A phase III randomized, double-blind, placebo-controlled trial of gabapentin in the management of hot flashes in men (N00CB)

Ann Oncol. 2009 Mar;20(3):542-9. doi: 10.1093/annonc/mdn644. Epub 2009 Jan 6.


Introduction: Hot flashes represent a significant problem in men undergoing androgen deprivation therapy.

Materials and methods: Via a prospective, double-blind, placebo-controlled clinical trial, men with hot flashes, on a stable androgen deprivation therapy program for prostate cancer, received a placebo or gabapentin at target doses of 300, 600, or 900 mg/day. Hot flash frequencies and severities were recorded daily during a baseline week and for 4 weeks while the patients took the study medication.

Results: In the 214 eligible patients who began the study drug on this trial, comparing the fourth treatment week to the baseline week, mean hot flash scores decreased in the placebo group by 4.1 units and in the three increasing dose gabapentin groups by, 3.2, 4.6, and 7.0 units. Comparing the three combined gabapentin arms to the placebo arm did not result in significant hot flash differences. Wilcoxon rank-sum P values for change in hot flash scores and frequencies after 4 weeks of treatment were 0.10 and 0.02, comparing the highest dose gabapentin arm to the placebo arm, respectively. The gabapentin was well tolerated in this trial.

Conclusion: These results support that gabapentin decreases hot flashes, to a moderate degree, in men with androgen ablation-related vasomotor dysfunction.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Aged, 80 and over
  • Amines / therapeutic use*
  • Androgen Antagonists / adverse effects*
  • Androgen Antagonists / therapeutic use
  • Cyclohexanecarboxylic Acids / therapeutic use*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Gabapentin
  • Hot Flashes / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Placebos
  • Prostatic Neoplasms / drug therapy*
  • gamma-Aminobutyric Acid / therapeutic use*


  • Amines
  • Androgen Antagonists
  • Cyclohexanecarboxylic Acids
  • Placebos
  • gamma-Aminobutyric Acid
  • Gabapentin