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Testim (Testosterone) - Summary

 
 



WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

  • Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions and Adverse Reactions].
  • Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel [see Dosage and Administration and Warnings and Precautions]
  • Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration Warnings and Precautions and Patient Counseling Information].
 

TESTIM SUMMARY

Testim® (testosterone gel) is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen.  Testim provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and/or upper arms. One 5-g or two 5-g tubes of Testim contains 50 mg or 100 mg of testosterone, respectively, to be applied daily to the skin’s surface.  Approximately 10% of the applied testosterone dose is absorbed across skin of average permeability during a 24-hour period. The active pharmacological ingredient in Testim is testosterone.

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 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.

Limitations of use:


  • Safety and efficacy of Testim in males less than 18 years old have not been established [see Use in Specific Populations ].
  • Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see Dosage and Administration and Clinical Pharmacology].

See all Testim indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Testim (Testosterone)

Difficult to predict low testosterone in older men using data on younger men
Source: Endocrinology News From Medical News Today [2016.06.22]
A new study published in CMAJ (Canadian Medical Association Journal) highlights the difficulty in defining and managing age-related testosterone decline in older men.

Low Testosterone (Low-T) in Men: Causes, Symptoms & Treatments
Source: MedicineNet Radiation Therapy Specialty [2016.06.02]
Title: Low Testosterone (Low-T) in Men: Causes, Symptoms & Treatments
Category: Slideshows
Created: 11/28/2012 12:00:00 AM
Last Editorial Review: 6/2/2016 12:00:00 AM

Prostate cancer: Testosterone therapy 'does not increase aggressive disease risk'
Source: Prostate / Prostate Cancer News From Medical News Today [2016.05.09]
A study using Swedish data finds men prescribed testosterone for over a year had no overall rise in prostate cancer risk, and they showed a 50 percent fall in aggressive disease.

Testosterone undecanoate improves sexual function in men with type 2 diabetes and very low testosterone
Source: Sexual Health / STDs News From Medical News Today [2016.05.06]
In a recent placebo-controlled study, long acting testosterone undecanoate (an ester of testosterone) improved erectile function, intercourse satisfaction, and sexual desire scores in type 2...

Study explains how low testosterone raises diabetes risk
Source: Prostate / Prostate Cancer News From Medical News Today [2016.04.29]
Doctors have long known that men with low testosterone are at greater risk for developing type 2 diabetes.

more news >>

Published Studies Related to Testim (Testosterone)

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

more studies >>

Clinical Trials Related to Testim (Testosterone)

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.

Testosterone for Penile Rehabilitation After Radical Prostatectomy [Terminated]
The purpose of this study is to determine the effectiveness of testosterone replacement therapy (TRT) in men following surgery to remove the prostate in improving erectile function. Subjects will be randomized (like flipping a coin) to one of two groups. One group will receive Testim (testosterone gel) 5 g per day plus Viagra 25 mg every night and the other will receive Placebo-Testim 5 g per day plus Viagra 25 mg every night. Subjects will begin drug treatment 3 months after the initial screening visit and will take study drug for 3 months only. Participation will end at the end of the 6-month visit.

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).

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.

A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203 [Completed]
The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12. 5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.

more trials >>

Reports of Suspected Testim (Testosterone) Side Effects

Oedema Peripheral (6)Fatigue (4)Prostate Cancer (4)Drug Ineffective (3)Dyspepsia (3)Blood Testosterone Decreased (3)Transient Ischaemic Attack (3)Nausea (3)Mitochondrial Myopathy Acquired (3)Gait Disturbance (3)more >>


Page last updated: 2016-06-22

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