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At least 19 recordsLinked to original sources
PubMed1999

Pharmacokinetics of new testosterone transdermal therapeutic systems in gonadotropin-releasing hormone antagonist-suppressed normal men.

In a phase I single-center, open, randomized pilot study with a three-way cross-over design the pharmacokinetics of three testosterone-containing transdermal therapeutic systems were evaluated in healthy male volunteers. Testosterone TTS HEXAL type 1 and 2 are nonscrotal membrane patches differing in the kind of adhesive used. 6 subjects were treated with low dose Testosterone TTS type 1, high dose Testosterone TTS type 1 and low dose Testosterone TTS type 2. To eliminate the influence of endogenous serum testosterone, the endogenous testosterone secretion was suppressed by the GnRH antagonist cetrorelix. In all subjects under GnRH antagonist treatment a marked suppression of LH, FSH, testosterone, DHT and estradiol was observed. Physiologic testosterone levels were achieved during the 24-hour-application period. Maximal serum levels were reached after 4 hours with both TTS systems. Both systems appear suited for further testing because both enable a physiological circadian profile to be achieved. GnRH-antagonist pretreatment is a useful model to evaluate the effect of exogenous testosterone in clinical studies, when, due to fluctuations in endogenous hormone levels, an estimation of the proportion of exogenous steroid is not possible.

Administration, Cutaneous↗
PubMed1989

Testosterone replacement with transdermal therapeutic systems. Physiological serum testosterone and elevated dihydrotestosterone levels.

Testosterone was administered transdermally to hypogonadal men under three protocols. In the first protocol, it was shown that peak levels of testosterone were achieved three to eight hours after scrotal application of a transdermal therapeutic system containing 5, 10, or 15 mg of testosterone, and values at 22 hours were greater than 60% of peak values. In the second protocol, patients were treated with 10-mg systems for four weeks followed by 15-mg systems for eight weeks. Serum samples were obtained three to five hours after application of the transdermal therapeutic system. Testosterone increased from a pretreatment level (mean +/- SE) of 1.5 +/- 0.4 nmol/L to 15.2 +/- 3.4 nmol/L at four weeks, 18.6 +/- 3.3 nmol/L at eight weeks, and 17.3 +/- 2.8 nmol/L at 12 weeks. The serum testosterone/dihydrotestosterone (DHT) ratio fell from 4.53 to 2.47 at four weeks and was similar at eight and 12 weeks, reflecting a greater rise in DHT with this route of treatment (normal testosterone/DHT ratio, 9/1 to 12/1). Eight patients were treated with the 15-mg systems for an additional year. Seven of the eight were compliant and maintained serum testosterone levels (at six time points from two to 12 months [mean +/- SE] ) ranging from 11.5 +/- 1.2 to 44.9 +/- 2.4 nmol/L. It was possible to achieve physiological serum levels of testosterone by transdermal administration of testosterone in two thirds of our hypogonadal men.

Administration, Cutaneous↗
PubMed2004

Effect of testosterone supplementation on sexual function in hypogonadal men with erectile dysfunction.

OBJECTIVES: To evaluate the impact of normalization of testosterone levels in men with documented hypogonadism and erectile dysfunction on erectile function and sexual satisfaction. Although the data support the role of testosterone in the preservation of libido and nocturnal erectile function, the evidence supporting the use of testosterone supplementation in hypogonadal men with erectile dysfunction is weak. METHODS: This analysis used two validated questionnaires, the International Index of Erectile Function and the Erectile Dysfunction Inventory of Treatment Satisfaction, in a serial fashion at baseline (before treatment) and 1, 3, and 6 months after the achievement of a therapeutic testosterone level. RESULTS: A total of 32 men met all inclusion criteria; 69% of men achieved therapeutic testosterone levels using transdermal testosterone gel, 19% required a transdermal patch, and 12% required intramuscular delivery. Statistical significance was reached for the difference between the baseline and 1-month International Index of Erectile Function erectile function domain score and all post-treatment International Index of Erectile Function libido scores. A steady decrease occurred in the Erectile Dysfunction Inventory of Treatment Satisfaction scores from the 1 to 6-month values that reached statistical significance. CONCLUSIONS: In men with documented hypogonadism and erectile dysfunction, normalization of serum testosterone levels was associated with only short-term improvement in erectile function and sexual satisfaction. The use of testosterone supplementation in this population for the treatment of erectile dysfunction is questionable.

Administration, Cutaneous↗
PubMed2005

Erectile dysfunction in aging men: testosterone role in therapeutic protocols.

Aging in men is accompanied by a decrease in libido and sexual activity. Recently, it has been demonstrated that a significant proportion of men >60 yr of age has biochemical hypogonadism. Hypoandrogenism, which is associated with other conditions that negatively influence erectile activity, may be an important cofactor in the induction of erectile dysfunction and in the response to phosphodiesterase type 5 (PDE5) inhibitors in aging. In these patients, administration of 50 mg sildenafil or 3 mg apomorphine has no influence on erectile function. Recently we showed that, in hypogonadal subjects, testosterone treatment might stimulate endothelial and neuronal production of vasoactive substances like nitric oxide (NO). Furthermore it can improve endothelial repair mechanisms by increasing bone marrow-derived endothelial progenitor cell (EPC) number in the peripheral circulation. Finally, the normal response to pharmacological stimulation with apomorphine or sildenafil, observed in hypogonadal men treated with testosterone, indicates a positive role of this hormone in the central and peripheral control of erection, confirming the possible positive influence on endothelial function and PDE5 expression. Therefore, we suggest measuring plasma testosterone levels in aged men with erectile dysfunction and recommend treating them barring clinical contraindications. Testosterone plus PDE5 inhibitors may be beneficial in improving erectile function in hypogonadal men with erectile dysfunction who were unresponsive to PDE5 inhibitors alone.

Adult↗
PubMed1998

The therapeutic potential of testosterone patches.

In the last decade, transdermal delivery of testosterone (T) has been shown to be a safe and effective means of treating male hypogonadism. Transdermal T patches can provide for physiologic androgen replacement in over 90% of men with hypogonadism. In addition, T patches have been shown to be equivalent to im. T esters in restoring normal male libido,sexual function and bone mineral density without harmful side-effects.Furthermore, in sharp contrast to periodic im. injections of T, transdermal T patches, when used daily, restore the normal circadian rhythm of T levels. The physiological and clinical importance of these circadian patterns,however, is presently unknown. The first transdermal patch to be marketed is applied to shaved scrotal skin. Newer patches can be applied to non-scrotal skin; however, these patches are associated with a significant rate of skin reactions that may require discontinuation. The main drawback to transdermal T delivery is cost, ten to twenty times the monthly cost of im. T, the method currently used to treat most hypogonadal men.Nevertheless, transdermal T patches constitute a major advance in the therapy of male hypogonadism as they allow for safe, non-invasive administration of T.

Journal Article↗
PubMed1991

Hypogonadal impotence treated by transdermal testosterone.

The transdermal therapeutic system for testosterone (TTS-T) (ALZA Corp.), applied to the scrotal skin for twenty-two hours daily, was tested for twelve weeks on 4 men with hypogonadal impotence; 2 of these men wore TTS-T for as long as twenty-six months. The 40 cm2 system delivered a daily dose of 2.8 +/- 0.16 (S.E.) mg (nominal dose 2.4 mg) and the 60 cm2 system delivered a dose of 3.99 +/- 0.24 mg (nominal dose 3.6 mg). Both systems promptly increased serum testosterone and dihydrotestosterone (DHT) to physiologic levels, restoring normal erectile activity with an increased frequency of ejaculation and a positive effect on both mood and energy. There were no changes in serum sex binding globulin and estradiol, prostate or breast size, hematologic or liver function measures, or urinary flow and frequency. There were no significant changes in serum cholesterol or low-density lipoproteins, but high-density lipoproteins tended to decline slightly. There were no dermatologic problems associated with the system. The tenfold increase in DHT over baseline levels was attributed to 5-alpha reduction of testosterone in the scrotal skin. The TTS-T is convenient, reliable, and mimics normal physiologic testosterone secretion and levels more closely than conventional methods of testosterone replacement.

Administration, Cutaneous↗
PubMed1998

Dihydrotestosterone: a rationale for its use as a non-aromatizable androgen replacement therapeutic agent.

Testosterone therapy is commonly used to treat male hypogonadism, androgen deficiency of severe illness, androgen deficiency of ageing and microphallus in infancy. The effects of testosterone are mediated directly as testosterone or after conversion to either dihydrotestosterone (DHT) or oestradiol. DHT is a potent androgen and cannot be aromatized to oestrogens, therefore acting as a pure androgen. DHT has been proposed as an androgen replacement therapy, with possible advantages over testosterone in certain circumstances in the ageing population as well as in patients with gynaecomastia and microphallus. A potential advantage of DHT over testosterone as an androgen replacement therapy is the reported and seemingly paradoxically muted effects of DHT on prostate growth. The decreased effect of DHT compared with testosterone on the prostate gland of humans may be due to the decrease in intraprostatic oestradiol levels. The potential beneficial effect of less prostate growth after DHT requires substantiation and, if true, must be balanced against any negative effects that might occur on bone, lipids and sexuality when a pure androgen replaces treatment with an aromatizable androgen.

3-Oxo-5-alpha-Steroid 4-Dehydrogenase↗
PubMed1991

Effect of polyoxyethylene glycols (PEG) on properties of the matrix model of transdermal therapeutic system (TTS) with testosterone.

Polyoxyethylene glycols (PEG) are nontoxic substances, which ones do not irritate the skin, therefore can be used as pharmaceutical excipients to differentiate the properties of various matrices. The effect of variable content and molecular mass of PEG in cellulose acetate matrices on the testosterone solubility, the rate of water sorption and the release rate of testosterone from the matrix model of TTS was studied. It may be concluded that the testosterone solubility in matrices, the rate of water sorption by systems and the pharmaceutical availability of drug can be regulated on a relatively wide scale independently of molecular mass by the amounts of PEGs incorporated into matrices. It was found that in all cases of triphase matrices the liberation process of terosterone was well correlated with Higuchi's equation. The rate of water sorption by PEG and matrices may be described by the equation Q = k square root of t.

Administration, Cutaneous↗