Trace contamination of over-the-counter androstenedione and positive urinetest results for a nandrolone metabolite

Context Several anabolic steroids are sold over-the-counter (OTC) in the Un ited States, and their production is not regulated by the US Food and Drug Administration. Reports have suggested that use of these supplements can ca use positive urine test results for metabolites of the prohibited steroid n androlone. Objectives To assess the content and purity of OTC androstenedione and to d etermine if androstenedione and 19-norandrostenedione administration causes positive urine test results for 19-norandrosterone, a nandrolone metabolit e. Design Randomized controlled trial of androstenedione, open-label trial of 19-norandrostenedione, and mass spectrometry of androstenedione preparation s, conducted between October 1998 and April 2000. Setting Outpatient facility of a university hospital. Participants A total of 41 healthy men aged 20 to 44 years. Intervention Participants were randomly assigned to receive oral androstene dione, 100 mg/d (n = 13) or 300 mg/d (n = 11) for 7 days, or no androstened ione (n = 13); in addition, 4 patients received 10 mug of 19-norandrostened ione. Main Outcome Measures Content of OTC androstenedione preparations; level of 19-norandrosterone in urine samples, determined by mass spectrometry, comp ared among the 3 randomized groups at day 1 and day 7, and among the partic ipants who received 19-norandrostenedione from October 1998 to April 2000, Results All urine samples from participants treated with androstenedione co ntained 19-norandrosterone, while no samples from the no-androstenedione gr oup did, Urinary concentrations were averaged for day 1 vs day 7 measuremen ts; mean (SD) 19-norandrosterone concentrations in the 100-mg/d and 300-mg/ d groups were 3.8 (2.5) ng/mL and 10,2 (6.9) ng/mL, respectively (P = .006) ,The 19-norandrosterone content exceeded the cut-off for reporting positive cases (>2.0 ng/mL) in 20 of 24. The androstenedione preparation used was p ure at a sensitivity of 0.1%, but at 0.001% 19-norandrostenedione was found . For the 4 participants to whom 10 mug of 19-norandrostenedione was admini stered, 19-norandrosterone was found in all urine samples. Of 7 brands of a ndrostenedione analyzed at the 1% level, 1 contained no androstenedione, 1 contained 10 mg of testosterone, and 4 more contained 90% or less of the am ount stated on the label, Conclusion Our study suggests that trace contamination of androstenedione w ith 19-norandrostenedione is sufficient to cause urine test results positiv e for 19-norandrosterone, the standard marker for nandrolone use. Oral ster oid doses as small as 10 mug are absorbed and excreted in urine. Some brand s of androstenedione are grossly mislabeled. Careful analysis of androstene dione preparations is recommended in all studies of its biological effects.