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. 

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.

Long‐term substitution therapy of hypogonadal men with transscrotal testosterone over 7–10 years

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.

Pharmacokinetics, efficacy, and safety of a permeation-enhanced testosterone transdermal system in comparison with bi-weekly injections of testosterone enanthate for the treatment of hypogonadal men.

Although both treatments seem to be efficacious for replacing T in hypogonadal men, the more physiological sex hormone levels and profiles associated with TTD may offer possible advantages over i.m. in minimizing excessive stimulation of erythropoiesis, preventing/ameliorating gynecomastia, and not over-suppressing gonadotropins.

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).

Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men.

It is concluded that transdermal T gel application can efficiently and rapidly increase serum T and free T levels in hypogonadal men to within the normal range for most patients.

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.

Pharmacokinetics and metabolism of a permeation-enhanced testosterone transdermal system in hypogonadal men: influence of application site- -a clinical research center study.

The pharmacokinetics and metabolism of a permeation-enhanced testosterone (T) transdermal (TTD) system and the influence of application site were investigated in 34 hypogonadal men and the optimal sites of TTD system application were identified as the back, thigh, upper arm, and abdomen.

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

Physiologic testosterone levels in normal men suppress high-density lipoprotein cholesterol levels.

The results imply that androgen levels in the normal adult male range have a suppressive effect on HDL cholesterol concentration and may contribute to the increased risk for coronary artery disease in men.