Transdermal delivery of testosterone

Hadgraft, Jonathan; Lane, Majella E.

doi:10.1016/j.ejpb.2015.02.015

Cited by 36 publications

(19 citation statements)

References 60 publications

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“…Testosterone was selected as the representative chemical for this comparative study since it is one of the reference chemicals recommended in the OECD test guideline 428 to be tested periodically to demonstrate the performance of the method, particularly in laboratories that are less familiar with the in vitro method (OECD, 2004a). Furthermore testosterone has been widely studied over many years in human in vitro and in vivo models (Bronaugh and Franz, 1986) and as a therapeutic agent for a variety of medical purposes (Hadgraft and Lane, 2015). Although, our own laboratory (Heylings et al, 2007) and others (van de Sandt et al, 2004) have compared the dermal penetration properties of testosterone and other standard reference chemicals in different species in previous multilaboratory investigations, a new up-to-date evaluation of the OECD 428 approach using dermatomed skin and other methodological aspects that have been introduced over the years, may prove useful for others involved with these types of studies.…”

Section: Introductionmentioning

confidence: 99%

Dermal absorption of testosterone in human and pig skin in vitro

Heylings

Davies

Burton

2018

Toxicology in Vitro

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The OECD test guideline 428 for the assessment of dermal absorption in vitro has been in force for more than a decade. Various sectors of industry utilise the method for the registration of chemical products. These include the Agrochemical and Cosmetic sectors where the OECD test guideline and industry-specific guidance forms a key part of the human risk assessment process for new and existing products. This investigation has compared the dermal absorption characteristics of one of the OECD 428 reference chemicals, testosterone, in human and pig dermatomed skin. We used identical dosing and skin decontamination conditions for testosterone in Franz static diffusion cells. This included a full mass balance recovery of the dose applied and distribution of the compound in the different layers of the skin. Our investigation has shown that intact human skin provides a more effective barrier to the dermal absorption of testosterone compared with pig skin, when studied according to modern day in vitro dermal absorption guidance.

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Section: Introductionmentioning

confidence: 99%

Dermal absorption of testosterone in human and pig skin in vitro

Heylings

Davies

Burton

2018

Toxicology in Vitro

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“…Testosterone therapy is commonly delivered via the transdermal route using patches, gels or solutions. Transdermal administration has a number of advantages over the parenteral (deep subcutaneous or intramuscular) and oral routes including comparable or better bioavailability, better titratability, ease of administration and improved compliance . In the case of gels and solutions, one of the distinct disadvantages is the potential for inadvertent transfer of testosterone to other individuals following skin‐to‐skin contact.…”

Section: Discussionmentioning

confidence: 99%

Virilisation in siblings secondary to transdermal ‘bioidentical’ testosterone exposure

Huynh

Stewart²

2017

J Paediatrics Child Health

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Precocious puberty is the development of secondary sexual characteristics before the age of 8 years in girls (onset of thelarche) and 9 years in boys (increase in testicular volume). 1 Clinical and biochemical assessment is directed at determining whether the underlying process is gonadotrophin-dependent (central precocious puberty (CPP)), associated with activation of the hypothalamic-pituitary-gonadal (HPG) axis, or gonadotrophin-independent (peripheral precocious puberty (PPP)) which is char-acterised by elevated sex steroids but low gonadotrophin levels. Although less common, the clinical consequences of PPP are no less severe, and the diagnosis is crucial to ensure appropriate management. 2 The inherited forms of PPP include non-salt wasting forms of Congenital Adrenal Hyperplasia, McCune-Albright Syndrome (MAS) and familial male-limited precocious puberty. Acquired PPP occurs secondary to exposure to endogenous (eg. adrenal, gonadal or other malignancies) or exogenous sex ster-oids. 3 We present cases of siblings with virilisation from transder-mal exposure to 'bioidentical' testosterone (bioT). Case Reports The siblings were a 5-year 9-month old boy (Patient 1, PT1) and his 4-year 6-month old sister (Patient 2, PT2). PT1 was referred for concerns regarding increasing aggression and onset of masturbatory behaviour. There had also been gradual phallic enlargement, development of pubic and axillary hair and acceleration in growth velocity over a period of 18 months. There were no associated headaches, visual disturbances or abdominal, pelvic or scrotal/tes-ticular pain. There was no family history of pubertal disorders. Paternal pubertal timing was concordant with his peers. Maternal menarche occurred at age 11 years and she did not report men-strual irregularities or difficulties conceiving her two children. The marriage was non-consanguineous. The father was a keen cyclist. His libido was described as 'out of control' by his wife. On examination, PT1 had no cutaneous stigmata or increased pigmentation , his blood pressure was within the age-specific range, there were no abdominal or pelvic masses, and his neurological examination was unremarkable. His height was >97th percentile, weight >97th percentile. He had Tanner stage 3 genital (G3) development with increased scrotal size and rugosity, and a stretch penile length of 8.5 cm (>90th percentile) (Fig. 1). He had Tanner stage 2-3 pubic hair (PH2-3), and some early axillary hair (A1-2). His testicular volumes were pre-pubertal (2 mL on the left and 2-3 mL on the right). During the consultation, the parents revealed that PT2 had also developed emotional lability and onset of pubic hair development. Her examination revealed Tan-ner stage 2 pubic hair (PH2), no axillary hair (A1) and obvious clitoral enlargement. There was no evidence of thelarche (breast Tanner stage 1, B1). Both PT1 and PT2 had significant advancement in skeletal maturity on bone age assessment. The clinical, biochemical and radiological features of the two cases are sum-marised in Table 1....

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“…21,103 However, it appears these unfavorable hepatic effects appear to be associated with oral forms of T. 21 One of the major considerations for using patches as the vehicle of delivery for transdermal T is that they can cause significant skin irritation with prolonged use. 42,43 Therefore, in men with SCI if patches are worn below the level of injury, we advise regular skin checks from caregivers as a loss of sensation in the patient might prevent the early detection of soreness or skin irritation.…”

Section: Safety Of Testosterone Replacement Therapymentioning

confidence: 99%

“…41 However, this mini-review aims to primarily focus on transdermal (i.e. patch or gel) TRT administration for the following reasons; (i) elevated patient compliance compared to other methods of delivery and convenience of administration, 42 (ii) effective at sustaining plasma T levels over 24 hours in a way that mimics the human body's natural T production cycle 43 and, (iii) high bioavailability. The aim of this review is to discuss the impact of transdermal TRT on body composition changes, with relevance to persons with SCI.…”

Section: Introductionmentioning

confidence: 99%

Body composition changes with testosterone replacement therapy following spinal cord injury and aging: A mini review

Nightingale

Moore

Harman

et al. 2017

The Journal of Spinal Cord Medicine

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Context Hypogonadism is a male clinical condition in which the body does not produce enough testosterone. Testosterone plays a key role in maintaining body composition, bone mineral density, sexual function, mood, erythropoiesis, cognition and quality of life. Hypogonadism can occur due to several underlying pathologies during aging and in men with physical disabilities, such as spinal cord injury (SCI). This condition is often under diagnosed and as a result, symptoms undertreated. Methods In this mini-review, we propose that testosterone replacement therapy (TRT) may be a viable strategy to improve lean body mass (LBM) and fat mass (FM) in men with SCI. Evidence Synthesis Supplementing the limited data from SCI cohorts with consistent findings from studies in non-disabled aging men, we present evidence that, relative to placebo, transdermal TRT can increase LBM and reduce FM over 3-36 months. The impact of TRT on bone mineral density and metabolism is also discussed, with particular relevance for persons with SCI. Moreover, the risks of TRT remain controversial and pertinent safety considerations related to transdermal administration are outlined. Conclusion Further research is necessary to help develop clinical guidelines for the specific dose and duration of TRT in persons with SCI. Therefore, we call for more high-quality randomized controlled trials to examine the efficacy and safety of TRT in this population, which experiences an increased risk of cardiometabolic diseases as a result of deleterious body composition changes after injury.

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Transdermal delivery of testosterone

Cited by 36 publications

References 60 publications

Dermal absorption of testosterone in human and pig skin in vitro

Dermal absorption of testosterone in human and pig skin in vitro

Virilisation in siblings secondary to transdermal ‘bioidentical’ testosterone exposure

Body composition changes with testosterone replacement therapy following spinal cord injury and aging: A mini review

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