Testim® 1% (testosterone gel) CIII
Testim® (testosterone gel) is a clear to translucent hydroalcoholic topical gel containing 1% testosterone. Testim® provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and upper arms.
Testim® is indicated for testosterone 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 cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, 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 levels but have gonadotropins in the normal or low range.
Testim® has not been clinically evaluated in males under 18 years of age.
Media Articles Related to Testim (Testosterone)
A SMARTer approach to stroke care
Source: MRI / PET / Ultrasound News From Medical News Today [2015.05.17]
NIH study uses MRI scans to screen stroke patients for acute treatment within the first critical 60 minutesTime is critical when it comes to stroke, and early treatment is associated with better...
Low Testosterone (Low T)
Source: MedicineNet Brain Tumor 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
Studies Suggest Testosterone Risks May Be Overstated for Some (CME/CE)
Source: MedPage Today Cardiovascular [2015.05.21]
(MedPage Today) -- Few risks and hint at benefits shown for older men with hypogonadism.
No Link Seen Between Testosterone and Prostate Cancer Risk (CME/CE)
Source: MedPage Today Oncology/Hematology [2015.05.20]
(MedPage Today) -- Meta-analyses find testosterone -- endogenous or supplemented -- is not associated with PSA levels.
Free Testosterone May Help Diagnose Hypogonadism
Source: Medscape Diabetes & Endocrinology Headlines [2015.05.19]
Measuring low free testosterone as well as total testosterone may provide a better diagnosis of testosterone deficiency, a new analysis from the world's largest study of aging men indicates.
Medscape Medical News
Published Studies Related to Testim (Testosterone)
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
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
Pharmacokinetics of testosterone and estradiol gel preparations in healthy young
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. 
alone or combined with NES gel in suppressing spermatogenesis... CONCLUSION: A combination of daily NES+T gels suppressed sperm concentration to 1
Clinical Trials Related to Testim (Testosterone)
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.
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
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.
Influence of Administration Route of Testosterone on Male Fertility [Not yet recruiting]
Exogenously administered testosterone will override the normal negative feedback of
endogenous testosterone on the hypothalamus and pituitary. Constantly, relatively high and
constant testosterone levels will cause a drop in FSH and LH production by the pituitary.
Since FSH and LH are signalling hormones to the testes, endogenous testosterone production
and spermatogenesis will be down-regulated. It is expected that intranasal dosing in the
morning will mimic the normal physiological pattern of testosterone production thereby
avoiding negative side-effects on spermatogenesis. Trans-dermal gels give testosterone
levels more or less constant over the day and will very likely have inhibitory effects on
The main objective of this study is to show that twice daily intranasal dosing does not
have, or has a smaller inhibitory effect on spermatogenesis in comparison to transdermal
Effect of Testosterone in Men With Erectile Dysfunction [Recruiting]
The purpose of this placebo-controlled study is to determine if testosterone replacement
therapy, administered by transdermal gel, can improve the response to sildenafil (Viagra R)
treatment in men who have erectile dysfunction (ED) and low testosterone levels.
Reports of Suspected Testim (Testosterone) Side Effects
Oedema Peripheral (6),
Prostate Cancer (4),
Drug Ineffective (3),
Blood Testosterone Decreased (3),
Transient Ischaemic Attack (3),
Mitochondrial Myopathy Acquired (3),
Gait Disturbance (3), more >>