Secondary exposure to testosterone from patients receiving replacement therapy with transdermal testosterone gels

Miller, Michael G.; Rogol, Alan D.; ZumBrunnen, Troy L.

doi:10.1185/03007995.2011.652255

Cited by 10 publications

(15 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Pharmacokinetic studies suggest that serum concentrations of testosterone in adult males normalise within 24–48 h after ceasing topical treatment . While this is believed to be true in children following a single exposure, the length of time taken for normalisation of testosterone levels in young children and infants with repeated exposure noted in the patients presented here was unexpected. Infants and children are particularly susceptible to transfer of topical hormone preparations due to their greater body surface area ratio to volume and increased skin permeability .…”

Section: Discussionmentioning

confidence: 53%

“…Infants and children are particularly susceptible to transfer of topical hormone preparations due to their greater body surface area ratio to volume and increased skin permeability. 2 Young children also have brown adipose tissue which in addition to being highly vascularised also contains androgen receptors 14 ; which may further contribute to increased testosterone absorption. Moreover, younger children are more likely to be held, have a greater chance of bed sharing and therefore are at increased risk of skin-to-skin contact resulting in increased testosterone absorption.…”

Section: Discussionmentioning

confidence: 99%

“…the use of testosterone replacement therapy) . Clinical signs of androgen excess include the presence of pubic and/or axillary hair, acne, clitoromegaly or increase in penile length and accelerated linear growth . These signs are abnormal in females under 8 years of age and males under 9 years of age and may persist even after normalisation of testosterone levels .…”

Section: Clinical and Biochemical Profile At Initial Presentationmentioning

confidence: 99%

“…1 Clinical signs of androgen excess include the presence of pubic and/or axillary hair, acne, clitoromegaly or increase in penile length and accelerated linear growth. 2 These signs are abnormal in females under 8 years of age and males under 9 years of age and may persist even after normalisation of testosterone levels. 2 This case series summarises four children's presentations requiring a clinical review due to signs of virilisation secondary to parental testosterone exposure.…”

mentioning

confidence: 99%

See 3 more Smart Citations

Variable persistence of serum testosterone in infants and children exposed to topical testosterone

Sanderson

Abraham

Joseph

et al. 2020

J Paediatrics Child Health

View full text Add to dashboard Cite

Section: Discussionmentioning

confidence: 53%

Section: Discussionmentioning

confidence: 99%

Section: Clinical and Biochemical Profile At Initial Presentationmentioning

confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

Variable persistence of serum testosterone in infants and children exposed to topical testosterone

Sanderson

Abraham

Joseph

et al. 2020

J Paediatrics Child Health

View full text Add to dashboard Cite

“…1 Secondary exposure of women and children from patients receiving transdermal testosterone replacement therapy with testosterone gels has been reported. 2 Clinically significant changes can occur in women and children exposed to testosterone through accidental transfer. 3e8 Ronde reviewed the reports of accidental exposure to topical testosterone, from both published and unpublished cases.…”

Section: Introductionmentioning

confidence: 99%

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

Satonin

Mitchell

et al. 2016

The Journal of Sexual Medicine

View full text Add to dashboard Cite

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.

show abstract

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

Sjöström

Mount

Klocker

et al. 2022

Veterinary Record Open

View full text Add to dashboard Cite

Background Hormonal replacement therapy is widely used to treat conditions in humans, the most well‐known indication being the relief of menopausal symptoms in women. Many of the hormone‐containing products (HCP) are applied to the skin. This transdermal delivery poses a risk to animals and humans through secondary exposure, especially when product information is not strictly followed. The aim of this article is to raise awareness among veterinarians and human healthcare providers of this risk; based on evidence from spontaneous reporting of suspected adverse events (AEs) in animals and humans. Interventions are also explored to mitigate the risk of secondary exposure to transdermal HCP (THCP). Review of spontaneously reported suspected AEs The Swedish Medical Products Agency has received several, mainly serious, AE reports in animals and children following secondary exposure to THCPs. The AE reports were reviewed together with worldwide data from the EudraVigilance Veterinary database and human EudraVigilance Data Analysis System. The clinical signs reported in animals included persistent signs of oestrus, poor growth rate and birth defects. In humans, reported clinical signs included precocious puberty, unresolved virilisation, accelerated growth rate and female infertility. Conclusions It is important that THCP are used according to manufacturer's instructions and users are made aware of risks and mitigating measures. This review of AEs in animals and children provides evidence to show that the use of THCP poses a risk for secondary exposure. Efficient communication strategies that stretch across veterinary and human medicinal disciplines are required to raise mutual awareness and minimise the risk of AEs in animals and humans.

show abstract

Secondary exposure to testosterone from patients receiving replacement therapy with transdermal testosterone gels

Cited by 10 publications

References 15 publications

Variable persistence of serum testosterone in infants and children exposed to topical testosterone

Variable persistence of serum testosterone in infants and children exposed to topical testosterone

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

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

Contact Info

Product

Resources

About