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.
--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.
Media Articles Related to Delatestryl (Testosterone)
Testosterone Gel Not Effective for Ejaculatory Dysfunction
Source: Medscape Diabetes & Endocrinology Headlines [2015.07.27]
Overall in a placebo-controlled trial, testosterone 2% gel didn't seem to improve ejaculatory delay, force, or volume, but there was possible benefit for patients whose testosterone levels were normalized.
Medscape Medical News
No VTE Risk Seen With Testosterone Therapy (CME/CE)
Source: MedPage Today Endocrinology [2015.07.27]
(MedPage Today) -- Findings may help men make benefit-risk assessment for treating testosterone deficiency
UTMB study finds that testosterone therapy is not linked with blood clot disorders in veins
Source: Endocrinology News From Medical News Today [2015.07.20]
A new study from The University of Texas Medical Branch at Galveston of more than 30,000 commercially insured men is the first large comparative analysis to show that there is no link between...
Testosterone Tx No Help For Ejaculatory Dysfunction
Source: MedPage Today Dermatology [2015.07.12]
(MedPage Today) -- Randomized trial shows no benefit over placebo.
New recommendations address the diagnosis and management of testosterone deficiency
Source: Endocrinology News From Medical News Today [2015.07.10]
An expert panel convened by the International Society for Sexual Medicine has developed a detailed "Process of Care" for the diagnosis and management of testosterone deficiency in men.
Published Studies Related to Delatestryl (Testosterone)
Testosterone induces erythrocytosis via increased erythropoietin and suppressed
hepcidin: evidence for a new erythropoietin/hemoglobin set point. 
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. 
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. 
24-week study... CONCLUSION: Strength training in aging men with low-normal testosterone levels
Pharmacokinetics of testosterone and estradiol gel preparations in healthy young
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. 
alone or combined with NES gel in suppressing spermatogenesis... CONCLUSION: A combination of daily NES+T gels suppressed sperm concentration to 1
Clinical Trials Related to Delatestryl (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
Oral Androgens in Man-4: (Short Title: Oral T-4) [Completed]
The protocol was designed to address the hypothesis that oral testosterone enanthate plus
dutasteride can suppress the secretion of LH and FSH after four weeks of administration. In
addition, we will compare the gonadotropin suppression mediated by a dose of testosterone
enanthate (400 mg twice daily) that would be expected to maintain the serum testosterone in
the normal range throughout the day, with the same dose (800 mg once daily) administered once
daily. This larger once-daily dose is expected to result in a higher peak and lower trough
by the end of the dosing interval
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
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