DHEA in elderly women and DHEA or testosterone in elderly men

N Engl J Med. 2006 Oct 19;355(16):1647-59. doi: 10.1056/NEJMoa054629.


Background: Dehydroepiandrosterone (DHEA) and testosterone are widely promoted as antiaging supplements, but the long-term benefits, as compared with potential harm, are unknown.

Methods: We performed a 2-year, placebo-controlled, randomized, double-blind study involving 87 elderly men with low levels of the sulfated form of DHEA and bioavailable testosterone and 57 elderly women with low levels of sulfated DHEA. Among the men, 29 received DHEA, 27 received testosterone, and 31 received placebo. Among the women, 27 received DHEA and 30 received placebo. Outcome measures included physical performance, body composition, bone mineral density (BMD), glucose tolerance, and quality of life.

Results: As compared with the change from baseline to 24 months in the placebo group, subjects who received DHEA for 2 years had an increase in plasma levels of sulfated DHEA by a median of 3.4 microg per milliliter (9.2 micromol per liter) in men and by 3.8 microg per milliliter (10.3 micromol per liter) in women. Among men who received testosterone, the level of bioavailable testosterone increased by a median of 30.4 ng per deciliter (1.1 nmol per liter), as compared with the change in the placebo group. A separate analysis of men and women showed no significant effect of DHEA on body-composition measurements. Neither hormone altered the peak volume of oxygen consumed per minute, muscle strength, or insulin sensitivity. Men who received testosterone had a slight increase in fat-free mass, and men in both treatment groups had an increase in BMD at the femoral neck. Women who received DHEA had an increase in BMD at the ultradistal radius. Neither treatment improved the quality of life or had major adverse effects.

Conclusions: Neither DHEA nor low-dose testosterone replacement in elderly people has physiologically relevant beneficial effects on body composition, physical performance, insulin sensitivity, or quality of life. (ClinicalTrials.gov number, NCT00254371 [ClinicalTrials.gov].).

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aging / drug effects*
  • Body Composition / drug effects*
  • Bone Density / drug effects
  • Dehydroepiandrosterone / administration & dosage*
  • Dehydroepiandrosterone / adverse effects
  • Dehydroepiandrosterone / blood
  • Double-Blind Method
  • Estradiol / blood
  • Female
  • Hormone Replacement Therapy* / adverse effects
  • Humans
  • Insulin Resistance
  • Male
  • Middle Aged
  • Physical Fitness*
  • Quality of Life
  • Testosterone / administration & dosage*
  • Testosterone / adverse effects
  • Testosterone / blood
  • Treatment Failure


  • Testosterone
  • Dehydroepiandrosterone
  • Estradiol

Associated data

  • ClinicalTrials.gov/NCT00254371