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

  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},
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. 
Efficacy and safety of the 2% formulation of testosterone topical solution applied to the axillae in androgen‐deficient men
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
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
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
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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.
Alterations in hepatic lipase and lipoprotein subfractions with transdermal testosterone replacement therapy
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
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
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
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.


Enhanced transdermal delivery of testosterone across nonscrotal skin produces physiological concentrations of testosterone and its metabolites in hypogonadal men.
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.
Safety aspects of androgen therapy
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
Efficacy and safety of two-year therapy with transdermal clonidine for essential hypertension.
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.
Adverse dermatologic reactions to transdermal drug delivery systems.
Biological actions of androgens.
Though unnecessary for life itself, androgens are essential for the propagation of the species and for establishment and maintenance of the quality of life of males through their support of sexual
Influence of testosterone therapy on clinical and immunological features of autoimmune diseases associated with Klinefelter's syndrome.
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.
Castrated men exhibit bone loss: effect of calcitonin treatment on biochemical indices of bone remodeling.
Testosterone deficiency, like estrogen deficiency, is associated with accelerated bone loss in men who have undergone bilateral orchidectomy.