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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.


See all Delatestryl indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Delatestryl (Testosterone)

Check Homocysteine Before Considering Testosterone?
Source: Medscape NeurologyHeadlines [2014.04.17]
Testosterone may have negative consequences for cognition when oxidative stress is high, although only in white men. Researchers suggest measuring homocysteine before prescribing TRT.
Medscape Medical News

EMA Also Reviews Testosterone
Source: MedPage Today Endocrinology [2014.04.14]
(MedPage Today) -- The European Medicines Agency has initiated a review of testosterone therapies, joining the FDA in investigating potential cardiovascular side effects.

High and Low Testosterone Levels in Men
Source: MedicineNet Heart Attack Specialty [2014.04.14]
Title: High and Low Testosterone Levels in Men
Category: Doctor's & Expert's views on Symptoms
Created: 12/2/1999 10:25:00 PM
Last Editorial Review: 4/14/2014 12:00:00 AM

Coming This Week: EASL, Salt, and Testosterone
Source: MedPage Today Endocrinology [2014.04.13]
(MedPage Today) -- More news from the European Association for the Study of the Liver, another investigation on the risks of testosterone, and new data on the association between salt intake and CVD deaths will generate headlines this week.

Group Wants Testosterone Study Retracted
Source: MedPage Today Dermatology [2014.03.26]
(MedPage Today) -- The Androgen Study Group, a large group of physicians and researchers, is calling for the retraction of a paper linking testosterone and cardiovascular risks -- data that its authors are standing firmly behind.

more news >>

Published Studies Related to Delatestryl (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 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 testosterone alone.

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 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 >>


Page last updated: 2014-04-17

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