WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
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Virilization has been reported in children who were secondarily exposed to testosterone gel
[see Warnings and Precautions and Adverse Reactions].
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Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel
[see Dosage and Administration and Warnings and Precautions].
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Healthcare providers should advise patients to strictly adhere to recommended instructions for use
[see Dosage and Administration Warnings and Precautions and Patient Counseling Information].
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ANDROGEL SUMMARY
AndroGel 1.62% for topical use is a clear, colorless gel containing testosterone. Testosterone is an androgen.
AndroGel 1.62% 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, 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.
Important limitations of use:
- Safety and efficacy of AndroGel 1.62% in males less than 18 years old have not been established [see Use in Specific Populations ].
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Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see Indications and Usage (1), and Clinical Pharmacology].
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NEWS HIGHLIGHTS
Published Studies Related to Androgel (Testosterone Transdermal)
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
Clinical Trials Related to Androgel (Testosterone Transdermal)
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.
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.
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men [Recruiting]
Skeletal muscle loss is a common consequence of aging and in some individuals reaches a
level that compromises health and quality of life. Age-associated increases in cytokine and
inflammatory signaling may be important contributors to this process. In this project the
investigators will test the hypotheses that 1) testosterone will inhibit cytokine and
inflammatory signaling in skeletal muscles of older adults and 2) will augment the anabolic
response to increased skeletal muscle activity. The investigators will also assess the
practical question of whether testosterone injection and gel application elicit similar
responses. Resistance exercise will be used as a means of stimulating both inflammatory and
anabolic responses in skeletal muscle. In order to assess the effects of testosterone on
these responses, fourteen subjects will perform resistance exercise on two occasions
separated by 7 days. The first session will be performed prior to the initiation of
testosterone therapy and the second session will be performed after receiving testosterone
for 7 days.
Exogenous Testosterone Plus Dutasteride for the Treatment of Castrate Metastatic Prostate Cancer [Completed]
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.
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 >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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: 2015-08-10
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