Amount of Testosterone on Laundered Clothing After Use of Testosterone Topical 2% Solution by Healthy Male Volunteers

Abstract

Introduction Testosterone 2% solution (Axiron) applied to armpit(s) is used for replacement therapy in men with a deficiency of endogenous testosterone. Aim To determine the amount of testosterone on subjects' T-shirts 12 hours after applying testosterone solution, the residual testosterone on subjects' T-shirts after laundering, and the testosterone transferred to unworn textile items during laundering with worn T-shirts. Methods Healthy males ≥18 years old applied 2 × 1.5 mL of testosterone 2% solution to both axillae (total testosterone dose: 120 mg) and dressed in cotton long-sleeved T-shirts after a ≥3-minute waiting period. T-shirts were worn 12 hours before being removed and cut into halves, after which a 10 × 10 cm sample of each armpit area was excised for testosterone quantification before or after laundering with samples of unworn textiles. Main Outcome Measures Testosterone on worn T-shirts before and after laundering, and on unworn textiles laundered with the worn T-shirts. Results Twelve subjects enrolled and completed, with only minor adverse events. Mean testosterone in unwashed worn T-shirts was 7603 μg, with high between-subject variability (3359 μg to 13,069 μg), representing 13% of the dose to 1 armpit. Mean testosterone in worn, laundered T-shirts was 260 μg (7.55 μg to 1343 μg), representing 3% of the dose to 1 armpit. Mean transferred testosterone to other textiles during laundering ranged from 69 μg on texturized Dacron 56T Double to 10,402 μg on 87/13 nylon/Lycra knit, representing 0.0382% to 5.78% of the dose to 1 armpit. Conclusion Thirteen percent of the testosterone applied to axillae was transferred to T-shirts during wear. Ninety-seven percent of the transferred testosterone was removed from the T-shirts during washing, some of which was then absorbed to various degrees by other textiles. Clinical implications of these findings and biological activity of the remaining/transferred testosterone are unknown.

A review of adverse events in animals and children after secondary exposure to transdermal hormone‐containing medicinal products

“…One study identified a risk of transferring testosterone by clothing, 46 and another highlighted a risk of transferring topical products via bedding, 47 which adds a further complexity to the issue. Suitable alternative application sites would be the lower part of the belly, the groin or upper part of the thighs of human patients, which are already recommended in the product information for some THCP.…”