Liver Damage From Long-Term Methyltestosterone

Bird, Deborah; Vowles, K. D. J.

doi:10.1016/s0140-6736(77)90323-3

Cited by 13 publications

(6 citation statements)

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“…8,9 In the other hand many articles have shown that injection of artificial testosterone can induce undesired side effects such as benign prostatic hyperplasia, cardiovascular events and in many cases prostate cancer. [10][11][12][13][14] Therefore, identification of identical testosterone structure by Confocal Raman Spectroscopy can protect Leydig cells and support the continued the transdermal treatment protocol for minimizing the andropause symptomatology. The Nanotechnology is an important agent in medical sciences.…”

Section: Discussionmentioning

confidence: 99%

Effects of a New Testosterone Transdermal Delivery System, Biolipid B2®-Testosterone in Healthy Middle Aged Men: A Confocal Raman Spectroscopy Study

Botelho¹,

Queiróz²,

Freitas³

et al. 2013

J Pharm Sci Innov

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The Transdermal Delivery System (BIOLIPID B2®) is a nanoemulsion that can be applied directly to the skin by a metered pump to deliver hormones into the systemic circulation. The aims of this study were to assess the efficacy of BIOLIPID B2® to deliver testosterone systemically and evaluate the short-term effects on Thyroid-Stimulating Hormone (TSH), C-reactive protein (CRP) serum levels and blood pressure in middle aged men with testosterone deficiency. An open label randomized prospective study enrolled 14 Brazilian middle aged men with testosterone deficiency. The volunteers received in the forearm 50mg of transdermal BIOLIPID B2®-testosterone nanostructured formulation daily for 3 months. Confocal Raman Spectroscopy (CRS) was used to determine depth and concentration of testosterone on skin layers. Clinical parameters and serum concentrations were compared between the baseline and 3 months after treatment. Serum concentrations of testosterone, CPR and TSH changed significantly (p<0.05) after treatment. There was, also a significant change in the waist circumference, weight and body mass index (p>0.05) and no changes were observed in the blood pressure. No adverse events were attributed to this transdermal hormone replacement therapy protocol. The BIOLIPID B2® nanoemulsion formulation is safe and effective in reestablishing testosterone and Thyroid-Stimulating Hormone (TSH) serum levels. This transdermal protocol may serve as a strategy for hormone replacement therapy in middle aged men.

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Section: Discussionmentioning

confidence: 99%

Effects of a New Testosterone Transdermal Delivery System, Biolipid B2®-Testosterone in Healthy Middle Aged Men: A Confocal Raman Spectroscopy Study

Botelho¹,

Queiróz²,

Freitas³

et al. 2013

J Pharm Sci Innov

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“…A change in liver size or tenderness may herald the onset of this complication of steroid therapy [5]. Severe abdominal pain has been reported in several patients as a result of rupture and intraperitoneal hemorrhage [5,10]. Hepatic failure is another recognized complication [15,103].…”

Section: Ill Intrahepatic Cholestasismentioning

confidence: 99%

“…Tumors interpreted as H.C.A. have occurred in males on A.S. [10,14,65,73,110]. A few cases have been reported in several metabolic disorder such as type 1 glycogenosis and diabetes mellitus.…”

Section: Focal Nodularmentioning

confidence: 99%

Hepatic Lesions Caused by Anabolic and Contraceptive Steroids

Ishak¹

1981

Semin Liver Dis

139

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“…Behre [12] reported that oral administration of testosterone gives rise to wide fluctuations with high within and between individual variability in serum testosterone concentrations. It has been reported that methyltestosterone can cause hepatic toxicity and adversely affect cholesterol concentrations following long‐term usage [13–15].…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics of a new testosterone transdermal delivery system, TDS^®‐testosterone in healthy males

Chik¹,

Johnston²,

Tucker

et al. 2005

Brit J Clinical Pharma

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Aims The Transdermal Delivery System (TDS®) is a liquid formulation that can be applied to the skin via a metered pump spray to deliver drug to the systemic circulation. The aims of this study were to assess the ability of the TDS® preparation to deliver testosterone systemically, and to characterize the pharmacokinetic profiles of the hormone in healthy males. Methods An open label, comparative, randomized placebo controlled study involving three treatments and three periods with a minimum of a 1 week washout period was conducted. Twelve healthy males received 50 mg TDS®‐testosterone, TDS®‐placebo, and 50 mg of a commercially available topical testosterone preparation (Androgel®, 1% topical testosterone gel). Results The mean AUC(0,12 h) was higher following application of TDS®‐testosterone (61.8 ng ml−1 h), compared with Androgel® (57.7 ng ml−1 h) and TDS®‐placebo (50.7 ng ml−1 h. The mean Cmax (0,12 h) was similar for TDS®‐testosterone (6.6 ng ml−1) and Androgel® (6.5 ng ml−1) and these values were higher than those for TDS®‐placebo (5.7 ng ml−1). Analysis of variance showed that the 90% confidence intervals on the relative difference of the ratio for the AUC(0,12 h) and the Cmax (0,12 h) between TDS®‐testosterone and Androgel®, were contained within the bioequivalence limit (80, 125%) (Cmax 89.2, 112.3% and AUC 93.5, 120.5%). Serum testosterone concentrations were lower following TDS®‐Placebo and were not bioequivalent either to the gel or spray. Conclusions The TDS® preparation was shown to deliver testosterone systemically to humans and the concentrations of the hormone in the 12 h following TDS® administration were bioequivalent to an existing topical delivery gel.

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Liver Damage From Long-Term Methyltestosterone

Cited by 13 publications

References 0 publications

Effects of a New Testosterone Transdermal Delivery System, Biolipid B2®-Testosterone in Healthy Middle Aged Men: A Confocal Raman Spectroscopy Study

Effects of a New Testosterone Transdermal Delivery System, Biolipid B2®-Testosterone in Healthy Middle Aged Men: A Confocal Raman Spectroscopy Study

Hepatic Lesions Caused by Anabolic and Contraceptive Steroids

Pharmacokinetics of a new testosterone transdermal delivery system, TDS^®‐testosterone in healthy males

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Liver Damage From Long-Term Methyltestosterone

Cited by 13 publications

References 0 publications

Effects of a New Testosterone Transdermal Delivery System, Biolipid B2®-Testosterone in Healthy Middle Aged Men: A Confocal Raman Spectroscopy Study

Effects of a New Testosterone Transdermal Delivery System, Biolipid B2®-Testosterone in Healthy Middle Aged Men: A Confocal Raman Spectroscopy Study

Hepatic Lesions Caused by Anabolic and Contraceptive Steroids

Pharmacokinetics of a new testosterone transdermal delivery system, TDS®‐testosterone in healthy males

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Product

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Pharmacokinetics of a new testosterone transdermal delivery system, TDS^®‐testosterone in healthy males