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Thursday, May 9, 2013

Variable Accuracy of Testosterone Concentrations in Compounded Testosterone Products

Accuracy of Testosterone Concentrations in Compounded Testosterone Products

Ethan Grober; Andrea Bozovic; Fanipour Majid; Vathany Kulasingam; Eleftherios Diamandis

Abstract: 1510

Introduction and Objectives
Many patients with testosterone deficiency inquire about the use of compounded testosterone products as an option for testosterone replacement. The safety and accuracy of the active ingredients within these products is not well established. The current study evaluated the accuracy of the testosterone concentrations within testosterone gels and creams manufactured by compounding pharmacies.

Ten compounding pharmacies within Toronto with experience in compounding testosterone products were included in this study. All pharmacies were blinded as to the nature of the study. A standardized prescription for 50mg of compounded testosterone gel/cream applied once daily was presented to each pharmacy. Two independently compounded samples (batch 1 and 2) were analyzed from each of the 10 pharmacies 1 month apart. For quality control, several samples from each batch were tested. Testosterone concentrations in a 5g sachet of Androgel 1% (Abbott) and 5g tube of Testim 1% (Auxilium) were evaluated as controls. Samples were analyzed independently and in a blinded fashion by the Department of Laboratory Medicine at the University of Toronto. Measurement of testosterone concentration was performed using a modified liquid chromatography tandem mass spectrometry validated for serum testosterone. Results are reported as % testosterone recoved compared to the prescribed testosterone concentration.

Compounded formulations included 7 gels and 3 creams with a volume/daily dose ranging from 0.2ml -1.25ml. Product cost ranged from $26 to $75 for a 7-day supply. There was significant variability both within and between pharmacies with respect to the measured concentration of testosterone in the compounded products (Figure 1). In contrast, the concentration of testosterone within Androgel and Testim was consistent and accurate. Collectively, only 50% (batch 1) and 30% (batch 2) of the compounding pharmacies provided a product with a testosterone concentration within +/-20% of the prescribed dose. Two pharmacies compounded products with >20% of the prescribed dose. One pharmacy compounded a product with essentially no testosterone.

Testosterone concentrations in compounded testosterone products can be variable and potentially compromise the efficacy and safety of treatment.

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