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Pharmacokinetic Evaluation of Three Different Intramuscular Doses of Nandrolone Decanoate: Analysis of Serum and Urine Samples in Healthy Men

Department of Clinical Pharmacology and Kinetics (W.M.B., J.M.W.S.), International Regulatory Affairs (H.A.M.V.), and International Medical Services (T.B.P.G.), Organon, 5340BH Oss, The Netherlands; Xendo Laboratories (S.M.D.J.-V.D.V.), 9713 GZ Groningen, The Netherlands; and Focus Clinical Drug Development (A.P.), D-41460 Neuss, Germany

Address all correspondence and requests for reprints to: Dr. Wilma M. Bagchus, Department of Clinical Pharmacology and Kinetics, Section Clinical Pharmacology, XW3139, Organon, Molenstraat 110, P.O. Box 20, 5340BH Oss, The Netherlands. E-mail: wilma.bagchus{at}organon.com.

The pharmacokinetics of nandrolone in serum and urine were investigated in healthy young men after a single im injection of 50 mg (n = 20), 100 mg (n = 17), or 150 mg (n = 17) nandrolone decanoate. Blood samples were collected before treatment and for up to 32 d after dosing. In addition, in the 50- and 150-mg groups, 24-h urine samples were collected before treatment and on d 1, 7, and 33 after treatment; in the 150-mg group, additional samples were collected after 3 and 6 months. Serum concentrations and the area under the curve of nandrolone increased proportionally with the dose administered. The peak serum concentration ranged from 2.14 ng/ml in the 50-mg group to 4.26 ng/ml in the 100-mg group and 5.16 ng/ml in the 150-mg group. The peak serum concentration was reached after 30 h (50 and 100 mg) and 72 h (150 mg), whereas the terminal half-life was 7–12 d. In urine, pretreatment concentrations of 19-norandrosterone (19-NA) and/or 19-noretiocholanolone (19-NE) were detected in five of 37 subjects (14%). In the 50-mg group, 19-NA and/or 19-NE could be detected at least until 33 d after injection in 16 of 17 subjects (94%). In the 150-mg group, who were presumed to have not previously used nandrolone, nandrolone metabolites could be detected for up to 6 months in eight of 12 subjects (67%) for 19-NE and in 10 of 12 subjects (83%) for 19-NA.

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