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

Arver, Stefan; Dobs, Adrian S.; Meikle, A.W.; Caramelli, Kim E.; Rajaram, Lakshminaryan; Sanders, Steven W.; Mazer, Norman A.

doi:10.1046/j.1365-2265.1997.3071113.x

Cited by 119 publications

(83 citation statements)

References 11 publications

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“…These results are consistent with those reported in an earlier longterm study of TTD therapy by Arver et al (16). In contrast, IM therapy produced sex hormone levels that were more often outside (above) normal reference ranges.…”

Section: Discussionsupporting

confidence: 83%

“…Morning serum levels of T, BT, DHT, and E 2 were measured at weeks 2 (TTD group only), 4,8,12,16,20, and 24 of randomized treatment at the midpoint of the dosing interval (approximately 12 hours after TTD application or 7 days after IM injection). Assessment of normalization was based on average levels from week 2 (week 4 for IM) to week 24.…”

Section: Efficacy Assessmentsmentioning

confidence: 99%

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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*

Dobs

Meikle

Arver

et al. 1999

The Journal of Clinical Endocrinology &Amp; Metabolism

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128

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The pharmacokinetics, efficacy, and safety of the Androderm testosterone (T) transdermal system (TTD) and intramuscular T enanthate injections (IM) for the treatment of male hypogonadism were compared in a 24-week multicenter, randomized, parallel-group study. Sixty-six adult hypogonadal men (22-65 years of age) were withdrawn from prior IM treatment for 4 -6 weeks and then randomly assigned to treatment with TTD (two 2.5-mg systems applied nightly) or IM (200 mg injected every 2 weeks); there were 33 patients per group. Twenty-six patients in the TTD group and 32 in the IM group completed the study.TTD treatment produced circadian variations in the levels of total T, bioavailable T, dihydrotestosterone, and estradiol within the normal physiological ranges. IM treatment produced supraphysiological levels of T, bioavailable T, and estradiol (but not dihydrotestosterone) for several days after each injection. Mean morning sex hormone levels were within the normal range in greater proportions of TTD patients (range, 77-100%) than IM patients (range, 19 -84%). Both treatments normalized LH levels in approximately 50% of patients with primary hypogonadism; however, LH levels were suppressed to the subnormal range in 31% of IM patients vs. 0% of TTD patients. Both treatments maintained sexual function (assessed by questionnaire and Rigiscan) and mood (Beck Depression Inventory) at the prior treatment levels.Prostate-specific antigen levels, prostate volumes, and lipid and serum chemistry parameters were comparable in both treatment groups. Transient skin irritation from the patches was reported by 60% of the TTD patients, but caused only three patients (9%) to discontinue treatment. IM treatment produced local reactions in 33% of patients and was associated with significantly more abnormal hematocrit elevations (43.8% of patients) compared with TTD treatment (15.4% of patients). Gynecomastia resolved more frequently during TTD treatment (4 of 10 patients) than with IM treatment (1 of 9 patients).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 IM in minimizing excessive stimulation of erythropoiesis, preventing/ ameliorating gynecomastia, and not over-suppressing gonadotropins. (J Clin Endocrinol Metab 84: 3469 -3478, 1999)

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Section: Discussionsupporting

confidence: 83%

Section: Efficacy Assessmentsmentioning

confidence: 99%

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*

Dobs

Meikle

Arver

et al. 1999

The Journal of Clinical Endocrinology &Amp; Metabolism

Self Cite

128

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“…Transdermal testosterone decreases HDL-C and increases the CT/HDL ratio (35,36) (Tables 2 and 3) . Nevertheless, recent studies show no undesirable effects on lipid metabolism (37,38).…”

Section: Transdermal Androgenmentioning

confidence: 99%

Effects of androgen substitution on lipid profile in the adult and aging hypogonadal male

Schleich

Legros

2004

European Journal of Endocrinology

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The decrease in serum bioavailable testosterone may be responsible for the catabolic sequelae noticed in the aging man (decrease in libido, decrease in muscle mass, osteoporosis and increase in adiposity). After a brief review of androgen and lipid metabolism as well as their modifications with aging, we discuss current knowledge of the effects of androgen substitution on the lipid profile in hypogonadal men. The results of studies concerning the effect of androgen substitution therapy on lipids are conflicting but might be favorable. The small decrease in high-density lipoprotein cholesterol observed when administering standard dosages of testosterone is accompanied by a significant decrease in total cholesterol (CT) and low-density lipoprotein cholesterol. A counterbalancing of these effects plausibly accounts for the absence of increase cardiovascular risk. The currently available preparations are oral, injectable or transdermal formulations of natural testosterone. The development of new androgen preparations that are more potent, metabolically stable and tissue-specific will improve therapeutic benefits and reduce side effects. European Journal of Endocrinology 151 415-424

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“…Identical placebo patches were manufactured by Thera-Tech Inc. (Bloomingdale, IL, USA) Subjects applied two 2.5 mg patches at night, a dose that has previously been shown to raise levels of testosterone to within the normal range in 93% of hypogonadal men and to mimic the normal diurnal variation in hormone levels seen in vivo (27).…”

Section: Trial Drugmentioning

confidence: 99%

Testosterone does not adversely affect fibrinogen or tissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) levels in 46 men with chronic stable angina

et al. 2005

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Objective: In women, sex hormones cause increased morbidity and mortality in patients with coronary heart disease (CHD) and adversely affect the coagulation profile. We have studied the effect of physiological testosterone replacement therapy in men on coagulation factor expression, to determine if there is an increased risk of thrombosis. Methods: Double-blind, randomized, placebo-controlled trial of testosterone in 46 men with chronic stable angina. Measurements of free, total and bioavailable testosterone, luteinising hormone (LH) and follicle-stimulating hormone (FSH), estradiol, plasminogen activator inhibitor-1 (PAI-1), fibrinogen, tissue plasminogen activator (tPA) and full blood count were made at 0, 6 and 14 weeks.

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

Cited by 119 publications

References 11 publications

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*

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*

Effects of androgen substitution on lipid profile in the adult and aging hypogonadal male

Testosterone does not adversely affect fibrinogen or tissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) levels in 46 men with chronic stable angina

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