NANDROLONE SUMMARY
NANDROLONE DECANOATE INJECTION USP
FOR INTRAMUSCULAR USE C-III
Rx only
Nandrolone Decanoate is an anabolic steroid. Anabolic steroids are synthetic derivatives of testosterone. A sterile oleaginous solution containing per mL: Nandrolone Decanoate 100 mg with Benzyl Alcohol 10% as solubilizer/preservative, in Sesame Oil q.s., and Nandrolone Decanoate 200 mg with Benzyl Alcohol 5% as solubilizer/preservative, in Sesame Oil q.s.Nandrolone decanoate (C28H44O3) occurs as a fine, white to creamy white, crystalline powder.
Nandrolone decanoate is indicated for the management of the anemia of renal insufficiency and has been shown to increase hemoglobin and red cell mass. Surgically induced anephric patients have been reported to be less responsive.
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NEWS HIGHLIGHTS
Published Studies Related to Nandrolone
Effects of testosterone and nandrolone on cardiac function: a randomized, placebo-controlled study. [2007.02]
Background Androgens have striking effects on skeletal muscle, but the effects on human cardiac muscle function are not well defined, neither has the role of metabolic activation (aromatization, 5alpha reduction) of testosterone on cardiac muscle been directly studied.Conclusion Four weeks of treatment with testosterone or nandrolone had no benefical or adverse effects compared with placebo on cardiac function in healthy young men.
Effects of resistance exercise training and nandrolone decanoate on body composition and muscle function among patients who receive hemodialysis: A randomized, controlled trial. [2006.08]
Patients who are on hemodialysis commonly experience muscle wasting and weakness, which have a negative effect on physical functioning and quality of life. The objective of this study was to determine whether anabolic steroid administration and resistance exercise training induce anabolic effects among patients who receive maintenance hemodialysis...
Effects of nandrolone decanoate compared with placebo or testosterone on HIV-associated wasting. [2006.04]
Objectives Current research is unclear about the most effective pharmacological agents for managing the loss of weight and fat-free mass common in HIV/AIDS. The aim of this study was to compare nandrolone decanoate with placebo and testosterone... Nandrolone decanoate treatment resulted in greater increases in fat-free mass than placebo and demonstrated a trend for a significant increase when compared with testosterone.
Double-blind, placebo-controlled study of the efficacy of nandrolone laurate in the treatment of dobermanns with subclinical hepatitis. [2005.09.10]
Twenty-one three-year-old dobermanns with subclinical hepatitis were treated with nandrolone laurate or a placebo in a double-blind trial. The dogs were scored clinically before and after four months of treatment and they were evaluated by clinical biochemistry and liver biopsies.After the treatment no significant differences were observed between the two groups in any of the clinical biochemistry values; eight of the 21 dogs had no histological evidence of hepatitis and five other dogs had improved, but there was no significant difference between the responses of the two groups.
A randomized, placebo-controlled trial of nandrolone decanoate in human immunodeficiency virus-infected men with mild to moderate weight loss with recombinant human growth hormone as active reference treatment. [2005.08]
OBJECTIVE: We compared the effectiveness of a biweekly regimen of 150 mg nandrolone with placebo in HIV-infected men with mild to moderate weight loss and contrasted its effects against a Food and Drug Administration-approved regimen of recombinant human (rh)GH... CONCLUSION: We conclude that nandrolone is superior to placebo and not significantly different from a Food and Drug Administration-approved regimen of rhGH in improving lean body mass in HIV-infected men with mild to moderate weight loss.
Clinical Trials Related to Nandrolone
A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss [Completed]
The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will
cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting).
Wasting has become an AIDS-defining condition. In the past, most studies that examined
wasting treatments were limited to men. However, it appears that wasting in HIV-positive men
is linked to levels of testosterone (a hormone which affects men's bodies more than women's).
This study has been designed for women only, in order to best treat wasting in HIV-positive
women.
Risk of Positive Doping Tests Following Ingestion of Supplements Contaminated With Trace Quantities of Nandrolone Metabolites [Completed]
There is compelling evidence that some dietary supplements consumed by the general population
are manufactured and stored under conditions that lead to contamination of the end product
with small amounts of extraneous materials. In most cases, this is harmless, but for athletes
liable to drug testing as a consequence of their participation in sport, the potential
consequences of even trivial amounts of a prohibited substance may be catastrophic. Quality
control procedures for pharmaceutical products normally specify the absence of contaminants
at a level of more than 0. 1%, ie 1mg/g. However, in the case of an anabolic steroid such as
nandrolone, the amount that will cause a positive test has been estimated to be about 1-3µg
(Geyer et al, 2004). In the case of a supplement that is taken in high doses (20-30 g/d),
such as for example creatine, this means that a contamination level of something closer to
0. 00001% (ie 1µg/g) may cause a positive test. This work have been supported by recent
findings from our laboratory (Judkins et al, 2006). These data demonstrate that as little as
10μg of 19-noradrostenedione (19-NorAD) added to a creatine supplement resulted in a positive
doping test in all volunteers testing. This is one thousand times less that the purity level
specified for pharmaceutical agents and at this level, these contaminants are without any
pharmacological action.
Proposals are under development to regulate the sale of dietary supplements for use by
athletes to avoid accidental doping positives as a result of ingestion of contaminated
supplements. This requires a knowledge of the amounts of contaminant that is likely to cause
problems. The aim of the present study was to examine the urinary excretion pattern of
nandrolone metabolites following 1µg, 2. 5µg and 5µg doses of 19-norandrostendione in both
male and female subjects. The quantity of 19-norandrostenedione administered in this study is
representative of the amount previously reported as an undeclared contaminant in some dietary
supplements. Given the speculation surrounding positive doping cases being attributed to
ingestion of sports supplements contaminated with pro-hormones, this presents an important
consideration for both athletes and doping agencies, as well as supplement manufacturers.
Anabolic Steroids and Exercise in Hemodialysis Patients [Completed]
This is a study to find out whether an exercise program during dialysis or a drug called
nandrolone decanoate can increase muscle size and strenght in patients on dialysis.
Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation [Recruiting]
The purpose of the program is to study and characterize the outcome of burn injury with
particular attention to improving the rehabilitation of burn survivors, including children.
Various agents are assessed for effectiveness on long term burn outcome, such as growth
hormone, oxandrolone, propranolol, insulin, ketoconazole, inhospital exercise and home
exercise.
Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients [Recruiting]
This prospective, double-blinded study will determine the feasibility of determining the
efficacy of a weekly intramuscular injection of nandrolone (an anabolic steroid) in
malnourished ICU patients. The data from this study will also enable us to prepare a future
grant proposal with a calculated sample size necessary to deomonstrate an improvement in
clinical outcome.
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