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Androderm (Testosterone Transdermal) - Summary

 
 



ANDRODERM SUMMARY

Androderm (testosterone transdermal system) provides continuous delivery of testosterone (the primary endogenous androgen) for 24 hours following application to intact, non-scrotal skin (e.g., back, abdomen, thighs, upper arms).

Two strengths of Androderm are available which deliver in vivo 2.5 mg or 5 mg of testosterone per day across skin of average permeability.

Androderm (testosterone transdermal system) is indicated for testosterone replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone.

Primary hypogonadism (congenital or acquired)—Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations accompanied by gonadotropins (FSH, LH) above the normal range.

Secondary, i.e., hypogonadotropic hypogonadism (congenital or acquired)—idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations without associated elevation in gonadotropins. Appropriate adrenal cortical and thyroid hormone replacement therapy may be necessary in patients with multiple pituitary or hypothalamic abnormalities.


See all Androderm indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Androderm (Testosterone Transdermal)

Testosterone induces erythrocytosis via increased erythropoietin and suppressed hepcidin: evidence for a new erythropoietin/hemoglobin set point. [2014]
hematocrit remain unclear... CONCLUSIONS: Testosterone-induced increase in hemoglobin and hematocrit is

The role of androgen receptor CAG repeat polymorphism and other factors which affect the clinical response to testosterone replacement in metabolic syndrome and type 2 diabetes: TIMES2 sub-study. [2013]
TRT in the TIMES2 study... CONCLUSION: AR CAG affected the response of some variables to TRT in the TIMES2

Mechanical muscle function and lean body mass during supervised strength training and testosterone therapy in aging men with low-normal testosterone levels. [2013]
24-week study... CONCLUSION: Strength training in aging men with low-normal testosterone levels

Pharmacokinetics of testosterone and estradiol gel preparations in healthy young men. [2013]
The paucity of pharmacokinetic data on testosterone gel formulations and absence of such data on estradiol administration in healthy young men constitutes a fundamental gap of knowledge in behavioral endocrinological research. We addressed this issue in a double-blind and placebo controlled study in which we applied a topical gel containing either 150mg of testosterone (N=10), 2mg of estradiol (N=8) or a respective placebo (N=10) to 28 healthy young men...

A new combination of testosterone and nestorone transdermal gels for male hormonal contraception. [2012]
alone or combined with NES gel in suppressing spermatogenesis... CONCLUSION: A combination of daily NES+T gels suppressed sperm concentration to 1

more studies >>

Clinical Trials Related to Androderm (Testosterone Transdermal)

A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone [Active, not recruiting]
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.

Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride [Completed]
The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride

Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes [Completed]
This study is to investigate how well Androgel, when tested against placebo gel, helps to control blood sugar levels in males with type 2 diabetes who have low testosterone (the main male hormone) blood levels and are taking oral diabetic medicines alone or in combination with insulin.

Exogenous Testosterone Plus Dutasteride for the Treatment of Castrate Metastatic Prostate Cancer [Recruiting]
Usually, the male hormone testosterone makes prostate cancer cells grow. Lowering testosterone usually stops the growth of prostate cancer. However, after a period of time without testosterone, prostate cancer cells learn to grow again.

You are able to join this trial because your prostate cancer is growing even though you have very low levels of testosterone. Studies have shown that high doses of testosterone, in this situation, can cause prostate cancer cells to stop growing.

The investigators did a study several years ago in which the investigators gave high doses of testosterone to patients such as yourself. The investigators showed that giving testosterone in this situation was safe. The investigators also showed that the investigators could, in some cases, make the PSA go down using high-dose testosterone.

The investigators believe that they can improve this type of treatment by combining testosterone with another drug called dutasteride. Dutasteride is another type of hormone. It should make testosterone levels rise. The investigators believe that combination of dutasteride and testosterone will be more a more powerful regimen against your cancer than testosterone alone.

Effect of Androgel on Type 2 Diabetic Males With Hypogonadism [Recruiting]
This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.

more trials >>

Reports of Suspected Androderm (Testosterone Transdermal) Side Effects

Pain in Extremity (2)Rash (2)Joint Swelling (2)Drug Dose Omission (1)Scrotal Swelling (1)Pulmonary Embolism (1)Drug Abuse (1)Peripheral Embolism (1)Gynaecomastia (1)Joint Stiffness (1)more >>


Page last updated: 2014-11-30

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