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Benjamin Z. Leder, MD; Christopher Longcope, MD; Don H. Catlin, MD; Brian Ahrens; David A. Schoenfeld, PhD; Joel S. Finkelstein, MD

JAMA. 2000;283:779-782.

Context  Androstenedione, a steroid hormone and the major precursor to testosterone, is available without prescription and is purported to increase strength and athletic performance. The hormonal effects of androstenedione, however, are unknown.

Objective  To determine if oral administration of androstenedione increases serum testosterone levels in healthy men.

Design  Open-label randomized controlled trial conducted between October 1998 and April 1999.

Setting  General clinical research center of a tertiary-care, university-affiliated hospital.

Participants  Forty-two healthy men aged 20 to 40 years.

Intervention  Subjects were randomized to receive oral androstenedione (either 100 mg/d [n = 15] or 300 mg/d [n = 14]) or no androstenedione (n = 13) for 7 days.

Main Outcome Measures  Changes in serum testosterone, androstenedione, estrone, and estradiol levels, measured by frequent blood sampling, compared among the 3 treatment groups.

Results  Mean (SE) changes in the area under the curve (AUC) for serum testosterone concentrations were -2% (7%), -4% (4%), and 34% (14%) in the groups receiving 0, 100, and 300 mg/d of androstenedione, respectively. When compared with the control group, the change in testosterone AUC was significant for the 300-mg/d group (P<.001) but not for the 100-mg/d group (P = .48). Baseline testosterone levels, drawn 24 hours after androstenedione administration, did not change. Mean (SE) changes in the AUC for serum estradiol concentrations were 4% (6%), 42% (12%), and 128% (24%) in the groups receiving 0, 100, and 300 mg/d of androstenedione, respectively. When compared with the control group, the change in the estradiol AUC was significant for both the 300-mg/d (P<.001) and 100-mg/d (P = .002) groups. There was marked variability in individual responses for all measured sex steroids.

Conclusions  Our data suggest that oral androstenedione, when given in dosages of 300 mg/d, increases serum testosterone and estradiol concentrations in some healthy men.

Author Affiliations: Endocrine Unit, Department of Medicine (Drs Leder and Finkelstein), and Department of Biostatistics (Dr Schoenfeld), Massachusetts General Hospital, Boston; Departments of Medicine and Obstetrics and Gynecology, University of Massachusetts Medical School, Worcester (Dr Longcope); and Olympic Analytical Laboratory, Departments of Medicine (Dr Catlin) and Molecular and Medical Pharmacology (Dr Catlin and Mr Ahrens), University of California, Los Angeles.

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