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.

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NEWS HIGHLIGHTS

Published Studies Related to Androderm (Testosterone Transdermal)

Effects of Aromatase Inhibition on Bone Mineral Density and Bone Turnover in Older Men with Low Testosterone Levels. [2009.10.09]
Context: Aging is associated with declining gonadal steroid production, low bone mineral density (BMD), and fragility fractures... Aromatase inhibition does not improve skeletal health in aging men with low or low normal testosterone levels.

Effect of long-acting testosterone treatment on functional exercise capacity, skeletal muscle performance, insulin resistance, and baroreflex sensitivity in elderly patients with chronic heart failure a double-blind, placebo-controlled, randomized study. [2009.09.01]
OBJECTIVES: This study investigated the effect of a 12-week long-acting testosterone administration on maximal exercise capacity, ventilatory efficiency, muscle strength, insulin resistance, and baroreflex sensitivity (BRS) in elderly patients with chronic heart failure (CHF). BACKGROUND: CHF is characterized by a metabolic shift favoring catabolism and impairment in skeletal muscle bulk and function that could be involved in the pathophysiology of heart failure... CONCLUSIONS: These results suggest that long-acting testosterone therapy improves exercise capacity, muscle strength, glucose metabolism, and BRS in men with moderately severe CHF. Testosterone benefits seem to be mediated by metabolic and peripheral effects.

Interval to testosterone recovery after hormonal therapy for prostate cancer and risk of death. [2009.09.01]
PURPOSE: To assess whether the risk of death is associated with the time to testosterone recovery (TTR) after radiotherapy (RT) and hormonal therapy (HT) for prostate cancer (PCa)... CONCLUSION: The results of our study have shown that a longer TTR after RT plus 6 months of HT for unfavorable-risk PCa is associated with a lower risk of death in men with no or minimal comorbidity.

Effects of caponization and testosterone implantation on immunity in male chickens. [2009.09]
This study examined the effects of caponization using different doses of testosterone (TES) on sexuality, hematology, and immune responses in male chickens. Healthy male chickens were caponized at 12 wk of age and selected at 16 wk of age for a 10-wk experiment...

Fatty acid metabolism in the elderly: effects of dehydroepiandrosterone and testosterone replacement in hormonally deficient men and women. [2009.09]
CONTEXT: Aging, low dehydroepiandrosterone (DHEA), and testosterone are associated with increased adiposity and metabolic risk. Treatment with these hormones may improve these abnormalities. OBJECTIVE: The objective of the study was to determine effects of aging, DHEA, or testosterone replacement on adiposity, meal fat partitioning, and postabsorptive lipolysis... CONCLUSIONS: Aging, in the context of low DHEA sulfate (women and men) and bioavailable testosterone (men) concentrations, is associated with changes in meal fat partitioning and postabsorptive lipolysis that are not corrected by DHEA and only partly corrected by testosterone replacement.

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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.

Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat [Completed]
The purpose of this study is to see if treatment with testosterone will reduce abdominal fat in HIV-positive men.

Many HIV patients on antiretroviral therapy show an increase in abdominal fat. Studies have shown that treatment with testosterone may decrease abdominal fat. This study will determine if testosterone will reduce abdominal fat in HIV patients.

28-Day Study of Testosterone Co-Administered With Dutasteride in Hypogonadal Men [Terminated]
The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the effects of each compound on the other, and to look for any safety problems that may result when the 2 drugs are given together.

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