WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)].
Children should avoid contact with any unwashed or unclothed application sites in men using testosterone gel [see Dosage and Administration (2.2), Warnings and Precautions (5.2)].
Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration (2.2), Warnings and Precautions (5.2) and Patient Counseling Information (17)].
Testosterone gel is a clear, colorless hydroalcoholic gel containing testosterone.
The active pharmacologic ingredient in testosterone gel is testosterone, an androgen.
Testosterone is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary Hypogonadism (congenital or acquired) - testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelters syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range.
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 testosterone serum concentrations but have gonadotropins in the normal or low range.
Important limitations of use:
Safety and efficacy of testosterone gel in males less than 18 years old have not been established [ see Use in Specific Populations (8.4) ].
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. (1, 12.3)
Media Articles Related to Testosterone
AACE Responds to FDA Testosterone-Replacement Statement
Source: Medscape Diabetes & Endocrinology Headlines [2015.09.29]
The American Association of Clinical Endocrinologists issues recommendations for testosterone-replacement therapy following the FDA's March 2015 cautionary notice about increased cardiovascular risk.
Medscape Medical News
Men with 'low testosterone' have higher rates of depression
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2015.07.02]
Researchers at the George Washington University (GW), led by Michael S. Irwig, M.D.
ED worsened, testosterone levels decreased by some treatments of prostate enlargement
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2015.06.15]
Men with benign prostate enlargement who used finasteride (also known as proscar and propecia) to treat their condition, experienced worsening erectile dysfunction (ED) that did not resolve with...
Low Testosterone (Low T)
Source: MedicineNet Iron Overload Specialty [2015.05.22]
Title: Low Testosterone (Low T)
Category: Symptoms and Signs
Created: 5/22/2015 12:00:00 AM
Last Editorial Review: 5/22/2015 12:00:00 AM
Testosterone nasal gel works best at three doses a day, study finds
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2015.03.11]
A new testosterone nasal gel raises men's low testosterone levels to normal, with few side effects, according to the results of a phase 3 clinical trial presented at the Endocrine Society's 97th...
Published Studies Related to Testosterone
Testosterone replacement therapy in older male subjective memory complainers:
double-blind randomized crossover placebo-controlled clinical trial of
physiological assessment and safety. 
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. 
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. 
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. 
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. 
24-week study... CONCLUSION: Strength training in aging men with low-normal testosterone levels
Reports of Suspected Testosterone Side Effects
Drug Ineffective (56),
Blood Testosterone Decreased (21),
Drug Administered AT Inappropriate Site (19),
Accidental Exposure (15),
Blood Testosterone Increased (14),
Pulmonary Embolism (12),
Alopecia (12), more >>
Page last updated: 2015-09-29