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Depo-Testosterone (Testosterone Cypionate) - Summary

 
 



SUMMARY

Depo®-Testosterone
testosterone cypionate injection, USP    CIII

DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils.

DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.

2. Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.


See all Depo-Testosterone indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Depo-Testosterone (Testosterone)

Alcohol Intake Tied to Low Sperm Quality, High Testosterone
Source: Medscape Urology Headlines [2014.10.15]
Men who drank 40+ units of alcohol per week had 34% lower sperm concentration than those who drank 5 or fewer units.
Medscape Medical News

Low Testosterone (Low-T)
Source: MedicineNet Impotence (ED) Specialty [2014.10.15]
Title: Low Testosterone (Low-T)
Category: Diseases and Conditions
Created: 9/25/2013 12:00:00 AM
Last Editorial Review: 10/15/2014 12:00:00 AM

Testosterone Tx Acts as Prostate Tumor Promoter in Rats (CME/CE)
Source: MedPage Today Endocrinology [2014.10.13]
(MedPage Today) -- Study findings may have significant public health implications for the use of testosterone therapy in men.

EMA Panel Says No Heart Risk With Testosterone
Source: MedPage Today Endocrinology [2014.10.13]
(MedPage Today) -- But this is not the final word from the European Medicines Agency.

In rat model testosterone found to promote prostate cancer
Source: Endocrinology News From Medical News Today [2014.10.09]
A researcher who found that testosterone raised the risk of prostate tumors and exacerbated the effects of carcinogenic chemical exposure in rats is urging caution in prescribing testosterone therapy...

more news >>

Published Studies Related to Depo-Testosterone (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 Depo-Testosterone (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.

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.

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

more trials >>

Reports of Suspected Depo-Testosterone (Testosterone) Side Effects

Poor Quality Drug Administered (33)Burning Sensation (30)Drug Ineffective (11)Feeling Hot (8)Injection Site Pain (7)Malaise (6)Rash (5)Pain (4)Headache (4)Injection Site Swelling (4)more >>


Page last updated: 2014-10-15

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