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Testim (Testosterone) - Summary

 
 



TESTIM SUMMARY

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:

  1. 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.
  2. 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.


See all Testim indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Testim (Testosterone)

Testosterone therapy not found to increase heart attack risk
Source: Endocrinology News From Medical News Today [2014.07.04]
Testosterone prescriptions for older men in the United States have increased more than three-fold over the past decade.

Testosterone Products Must Warn About Risk of Venous Clots: FDA
Source: MedicineNet Deep Vein Thrombosis Specialty [2014.06.23]
Title: Testosterone Products Must Warn About Risk of Venous Clots: FDA
Category: Health News
Created: 6/20/2014 4:35:00 PM
Last Editorial Review: 6/23/2014 12:00:00 AM

Testosterone deficiency can be identified with new screening questionnaire
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2014.04.27]
Men whose testosterone falls below normal levels are more likely to have erectile dysfunction and to be overweight and have heart disease and type 2 diabetes.

Low Testosterone (Low T)
Source: MedicineNet Klinefelter Syndrome Specialty [2013.09.26]
Title: Low Testosterone (Low T)
Category: Diseases and Conditions
Created: 12/14/2009 4:15:00 PM
Last Editorial Review: 9/26/2013 12:00:00 AM

Low Testosterone (Low-T)
Source: MedicineNet Impotence (ED) Specialty [2012.09.12]
Title: Low Testosterone (Low-T)
Category: Diseases and Conditions
Created: 9/25/2013 7:00:00 PM
Last Editorial Review: 9/12/2012 12:00:00 AM

more news >>

Published Studies Related to Testim (Testosterone)

A new combination of testosterone and nestorone transdermal gels for male hormonal contraception. [2012]
alone or combined with NES gel in suppressing spermatogenesis... CONCLUSION: A combination of daily NES+T gels suppressed sperm concentration to 1

Efficacy and safety of testosterone in the management of hypoactive sexual desire disorder in postmenopausal women. [2012]
Health... CONCLUSION: Transdermal testosterone appears to be an effective and safe therapy

A placebo-controlled, randomized clinical trial using testosterone undecanoate with injectable norethisterone enanthate: effect on anthropometric, metabolic and biochemical parameters. [2011.12]
Testosterone administered alone or in combination with progestogens in male contraception induces reversible oligo-azoospermia, but its effects on body composition and metabolism are less known. We analysed anthropometric and metabolic parameters in five groups of 10 males: four receiving testosterone undecanoate (TU: 1000 mg) plus norethisterone enanthate (NETE: 200 mg) at different intervals (every 8 weeks: NETE-8; every 12 weeks: NETE-12; every 6 weeks for 12 weeks and then every 12 weeks: NETE-6/12; every 6 weeks for 12 weeks and then TU plus placebo every 12 weeks : NETE-6/12/0) and one placebo (NETE-0/0) for a total of 48 weeks.

A randomized, double-blind, placebo-controlled trial on the effect of long-acting testosterone treatment as assessed by the Aging Male Symptoms scale. [2011.11.17]
Study Type - Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Testosterone deficiency syndrome can be treated with testosterone replacement in the form of injectable, transdermal, buccal and oral preparations. Long-acting i.m. testosterone undecanoate 1000 mg, which is given at 10-14 week intervals, has been shown to be adequate for sustaining normal testosterone levels in hypogonadal men. This study confirms that long-acting i.m. testosterone undecanoate is effective in improving the health-related quality of life in men with testosterone deficiency syndrome as assessed by the improvement in the Aging Male Symptoms scale. Testosterone treatment can be indicated in men who have poor health-related quality of life resulting from testosterone deficiency syndrome. OBJECTIVE: * To evaluate the effect of i.m. injection of testosterone undecanoate 1000 mg over 12 months on the Aging Male Symptom (AMS) scale scores in men with testosterone deficiency syndrome (TDS)... CONCLUSION: * Long-acting testosterone is effective in improving health-related quality of life as assessed by the AMS scale in men with TDS. (c) 2011 THE AUTHORS. BJU INTERNATIONAL (c) 2011 BJU INTERNATIONAL.

A randomized pilot study of monthly cycled testosterone replacement or continuous testosterone replacement versus placebo in older men. [2011.11]
Context: Cycling androgens has been reported by athletes to improve physical performance by enhancing muscle mass and strength, a paradigm that has not been studied, and may have clinical value in older men being treated with testosterone... Conclusions: Cycled testosterone improved body composition and increased muscle strength compared with placebo and increased FSR similarly to continuous testosterone.

more studies >>

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 testosterone alone.

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 spermatogenesis.

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 testosterone gels.

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.

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: 2014-07-04

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