Long‐term efficacy and safety of a permeation‐enhanced testosterone transdermal system in hypogonadal men

@article{Arver1997LongtermEA,
  title={Long‐term efficacy and safety of a permeation‐enhanced testosterone transdermal system in hypogonadal men},
  author={Stefan Arver and Adrian S. Dobs and A. Wayne Meikle and Kim E. Caramelli and Lakshminaryan Rajaram and Steven W. Sanders and Norman A. Mazer},
  journal={Clinical Endocrinology},
  year={1997},
  volume={47}
}
An important aim in treating male hypogonadism is restoration of physiological concentrations of testosterone and its metabolites. We have assessed hormone levels, pharmacokinetics and clinical response, including safety, of a permeation‐enhanced testosterone transdermal system (TTD) in the treatment of hypogonadal men for a 12‐month period. 
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136 Citations
Highly Influential Citations
5
Background Citations
33
Methods Citations
3
Results Citations
2

136 Citations

Efficacy and safety of the 2% formulation of testosterone topical solution applied to the axillae in androgen‐deficient men
TLDR
Testosterone replacement therapy in hypogonadal men relieves symptoms and restores serum testosterone levels to the physiological range and the safety, pharmacokinetics, and efficacy of the 2% formulation of testosterone topical solution applied daily to the axillae are assessed.
A novel testosterone gel formulation normalizes androgen levels in hypogonadal men, with improvements in body composition and sexual function
TLDR
To compare the safety and efficacy of two doses of a new testosterone gel formulation to a permeation‐enhanced testosterone patch for treating men with confirmed low serum testosterone levels, and associated signs and symptoms of hypogonadism.
Transdermal testosterone gel: pharmacokinetics, efficacy of dosing and application site in hypogonadal men
TLDR
The authors from the USA evaluated the pharmacokinetics and the efficacy of dosing and application sites of another such transdermal gel.
Randomized placebo‐controlled trial of testosterone replacement in men with mild Leydig cell insufficiency following cytotoxic chemotherapy
OBJECTIVE Testosterone deficiency is associated with significant morbidity, and androgen replacement in overt hypogonadism is clearly beneficial. However, there are few data concerning the response…
Long‐term substitution therapy of hypogonadal men with transscrotal testosterone over 7–10 years
TLDR
To assess the quality of this new form of T substitution, hypogonadal men treated by transdermal T up to 10 years were followed and scrotal T patches were followed.
Improvement of sexual function in testosterone deficient men treated for 1 year with a permeation enhanced testosterone transdermal system.
Alterations in hepatic lipase and lipoprotein subfractions with transdermal testosterone replacement therapy
TLDR
Evaluated the effects of testosterone replacement therapy given transdermally via a permeation‐enhanced system on plasma lipolytic enzymes (hepatic and lipoprotein lipase), LDL and HDL subfraction concentrations.
New Modalities of Transdermal Testosterone Replacement
TLDR
Transdermal testosterone replacement improves bone mass and lean body mass, decreases fat mass, and improves mood and sexual function, and there are no harmful effects on the prostate and lipids.
Prostate‐specific antigen (PSA) concentrations in hypogonadal men during 6 years of transdermal testosterone treatment
TLDR
It is shown that, over the long‐term, Testopatch was associated with no relevant changes in PSA concentration and PSA velocity, or any significant prostate risks (there were no cases of prostate cancer).
Drug Insight: testosterone preparations
TLDR
Transdermal patches, gels, mucoadhesive sustained-release buccal tablets and long-acting testosterone esters are designed to provide testosterone levels that approximate normal physiologic levels, to improve patient acceptability, and to further increase the number of treatment options available.
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References

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Improvement of sexual function in testosterone deficient men treated for 1 year with a permeation enhanced testosterone transdermal system.
Enhanced transdermal delivery of testosterone : a new physiological approach for androgen replacement in hypogonadal men
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TLDR
The results indicate that the enhanced transdermal delivery of T across nonscrotal skin is a patient-friendly androgen replacement modality and produces physiological concentrations of T and its metabolites, which are unattainable with other treatment modalities.
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Side effects of androgen androgen therapy may be directly related to the biological actions of testosterone itself or one of its physiological metabolites (dihydrotestosterone or estrogens). Side…
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TLDR
TC was effective as long-term monotherapy for essential hypertension in only four of the authors' patients, and the major limitation is skin-related side effects.
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TLDR
A therapeutic effect of T on autoimmune diseases in patients with hypogonadism and Klinefelter's syndrome is indicated and both the SS and SLE patients had a clinical remission of their autoimmune disease.
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TLDR
Testosterone deficiency, like estrogen deficiency, is associated with accelerated bone loss in men who have undergone bilateral orchidectomy.
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