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Delatestryl (Testosterone Enanthate) - Summary

 
 



DELATESTRYL SUMMARY

DELATESTRYL (Testosterone Enanthate Injection) provides testosterone enanthate, a derivative of the primary endogenous androgen testosterone, for intramuscular administration. In their active form, androgens have a 17-beta-hydroxy group. Esterification of the 17-beta-hyroxy group increases the duration of action of testosterone; hydrolysis to free testosterone occurs in vivo. Each mL of sterile, colorless to pale yellow solution provides 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol (chloral derivative) as a preservative.

DELATESTRYL (Testosterone Enanthate Injection) is indicated for replacement therapy in 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, or orchidectomy.

Hypogonadotropic hypogonadism (congenital or acquired) --Idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.)

If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.

Delayed puberty --DELATESTRYL (Testosterone Enanthate Injection) may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers (see WARNINGS).

Metastatic mammary cancer-- DELATESTRYL (Testoste-rone Enanthate Injection) may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. This treatment has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor. Judgment concerning androgen therapy should be made by an oncologist with expertise in this field.


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NEWS HIGHLIGHTS

Media Articles Related to Delatestryl (Testosterone)

Man With Micropenis Responds to Testosterone
Source: MedPageToday.com - medical news plus CME for physicians [2016.05.27]
(MedPage Today) -- Therapy helps Kallmann syndrome patient

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.

Studies show oral testosterone safe and efficacious in long-term management of hypogonadism
Source: Endocrinology News From Medical News Today [2016.05.08]
Research highlights safety and efficacy of novel treatment option for hypogonadism over 52-week periodLCPN10, a novel oral testosterone undecanoate formulation has been shown to be safe and...

Studies demonstrate protective effects of testosterone in hypogonadal men
Source: Endocrinology News From Medical News Today [2016.05.07]
Maintaining healthy levels of testosterone (T) may decrease a man's risk of developing not only prostate cancer, but also other metabolic conditions, according to new research being presented at the...

Testosterone undecanoate improves sexual function in men with type 2 diabetes and very low testosterone
Source: Endocrinology 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...

more news >>

Published Studies Related to Delatestryl (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

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Page last updated: 2016-05-27

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