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Androgel (Testosterone Transdermal) - Summary

 
 



ANDROGEL SUMMARY

AndroGel® (testosterone gel) is a clear, colorless hydroalcoholic gel containing 1% testosterone. AndroGel® provides continuous transdermal delivery of testosterone, the primary circulating endogenous androgen, for 24 hours following a single application to intact, clean, dry skin of the shoulders, upper arms and/or abdomen.

AndroGel® is indicated for replacement therapy in 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.

AndroGel® has not been clinically evaluated in males under 18 years of age.


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NEWS HIGHLIGHTS

Published Studies Related to Androgel (Testosterone Transdermal)

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

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

Pharmacokinetics of testosterone and estradiol gel preparations in healthy young men. [2013]
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. [2012]
alone or combined with NES gel in suppressing spermatogenesis... CONCLUSION: A combination of daily NES+T gels suppressed sperm concentration to 1

more studies >>

Clinical Trials Related to Androgel (Testosterone Transdermal)

Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes [Completed]
This study is to investigate how well Androgel, when tested against placebo gel, helps to control blood sugar levels in males with type 2 diabetes who have low testosterone (the main male hormone) blood levels and are taking oral diabetic medicines alone or in combination with insulin.

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.

AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment [Active, not recruiting]
We hypothesize that AndroGel may offer some relief to subjects with low or borderline testosterone levels who suffer from depression and have failed to respond to a trial of a standard antidepressant.

During this nine week, outpatient, double-blind study, male subjects between the ages of 30 and 65 years with treatment-refractory depression and low or borderline low testosterone levels will be treated with either AndroGel or placebo. Following this nine week, double-blind phase, eligible subjects will have the option to continue into a six month, open-label phase during which time all subjects will receive the AndroGel patch.

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.

more trials >>

Reports of Suspected Androgel (Testosterone Transdermal) Side Effects

Drug Ineffective (193)Blood Testosterone Decreased (188)Asthenia (71)Fatigue (70)Drug Administered AT Inappropriate Site (55)Feeling Abnormal (36)Blood Testosterone Increased (35)Oedema Peripheral (34)Libido Decreased (33)Blood Testosterone Abnormal (33)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Androgel has an overall score of 10. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Androgel review by 62 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   male andropause
Dosage & duration:   50 mg taken twice per day for the period of the last 8 years
Other conditions:   none
Other drugs taken:   HCG
  
Reported Results
Benefits:   Extremely better clarity of mind. Much higher energy. More strength. More optimism. More vigor.
Side effects:   At first I didn't realize that it was significantly converting to DHT and causing typical male pattern hairloss. Once I realized it was happening, I was able to slow it down greatly via a shampoo designed to block DHT (not systematically, just on the scalp).
Comments:   Rub gel on forearms twice per day. Extremely easy.

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Page last updated: 2014-11-30

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