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)
Testosterone replacement therapy in older male subjective memory complainers:
double-blind randomized crossover placebo-controlled clinical trial of
physiological assessment and safety. [2015] Testosterone replacement therapy (TRT) has been investigated in older men as a
preventative treatment against Alzheimer's disease and dementia. However,
previous studies have been contradictory... Our study suggests TRT is safe and well-tolerated in
this Indonesian cohort, yet longitudinal studies with larger cohorts are needed
to assess TRT further, and to establish whether TRT reduces dementia risk.
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
Effect of testosterone treatment on constitutional and sexual symptoms in men
with type 2 diabetes in a randomized, placebo-controlled clinical trial. [2014] constitutional and sexual symptoms in men with type 2 diabetes (T2D)... CONCLUSIONS: In this trial, T treatment did not substantially improve
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
Clinical Trials Related to Androderm (Testosterone Transdermal)
A Randomized Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer [Completed]
The purpose of this study is to see how safe Androderm® (the study drug) is at three
different doses in subjects with early hormone refractory prostate cancer. In addition,
information about hormonal levels and the effects of testosterone on quality of life
including sexual functioning and muscle strength will be collected.
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism [Active, not recruiting]
This is to study the effect of replacing testosterone on different inflammatory cells in
type 2 diabetics with low testosterone levels.
Safety Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women [Completed]
Female sexual dysfunction (FSD) is an established side effect of Selective serotonin
reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing
symptoms such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia.
Efficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder
(HSDD) in women has been demonstrated in studies including naturally and surgically
menopausal women, either alone or in combination with estrogen, with or without progestin
therapy.
TRADE-Testosterone Replacement and Dutasteride Effectiveness [Completed]
The purpose of this research study is to determine whether the combination of the male
hormone testosterone [T] in gel form and the oral drug dutasteride [D], used to shrink large
prostate glands can safely reduce the size of the prostate gland and symptoms of prostate
enlargement (called benign prostatic hyperplasia [BPH]) compared to T treatment alone in men
with low testosterone (called hypogonadism).
Pharmacokinetic Study of Testosterone Enanthate [Completed]
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 >>
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Page last updated: 2015-08-10
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