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If you stay on steroids all the time. Trt,hrt,crusing,or bridging this is a must read

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needtogetaas

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Nebido:Testosterone Undecanoate or other drug names like
Reandron 1000 ( we are talking about the injectable form of this steroids) Or for any of you nomenclature lovers ( like me) out there (17β)-17-[(1-Oxoundecyl)oxy]-androst-4-en-3-
one :biggrin:
For the real steroid geeks
Molecular formula: C30H48O3
Molecular weight: 456.7
CAS Number: 5949-44-0


Endo Pharmaceuticals (Nasdaq: ENDP) released new long-term clinical trial data in men with hypogonadism who were treated for 21 months with testosterone undecanoate (NEBIDO(R) -- 750 mg) injection, a long-acting testosterone replacement therapy in development in the U.S. for treatment of hypogonadism. Results showed that average testosterone levels were maintained within the normal range over the 21-month study, and NEBIDO was generally well tolerated. The long-term clinical trial data were presented at the annual meeting of the American Urological Association.

Previously reported Phase III data evaluated NEBIDO's effectiveness and safety over the initial six-month treatment period in these hypogonadal men, with 94 percent of patients achieving an average testosterone level within the normal range (300-1000 ng/dL) over the 10-week treatment interval. At initiation of treatment, the average testosterone level for the patients rose into the normal range at the first sampling point, four days following the first injection. The new long-term data showed that average testosterone levels remained in the normal range throughout the 21-month study, and that NEBIDO was generally well tolerated. NEBIDO is currently under review at the U.S. Food and Drug Administration.

"Symptoms of low testosterone can be non-specific and may be dismissed as the natural consequence of aging," said Dr. Abraham Morgentaler, a leading investigator of the study and Director of Men's Health Boston, and Associate Clinical Professor of Urology at Harvard Medical School. "But treating hypogonadism can result in significant health benefits for patients."

STUDY RESULTS

This open-label study enrolled 130 hypogonadal men with serum testosterone levels below 300 ng/dL at study entry. NEBIDO was dosed as an intramuscular injection (750 mg) at baseline, at week four, and then every 10 weeks throughout the remainder of the 21-month study. Approximately 70 percent of patients completed all NEBIDO injections.

Evaluation of testosterone levels showed that average concentrations were consistent from one injection to the next.

Safety data showed that NEBIDO was generally well tolerated over the 21-month study, with reported side effects typically characterized as mild and non-serious. The most common side effects reported were acne (6.2 percent) and increased prostate specific antigen (5.4 percent).

Dr. Morgentaler noted: "Because men who suffer from hypogonadism need to remain on treatment for life, it is very important that they can have a treatment option that is well tolerated. Transdermal patches and gels that must be applied to the skin on a daily basis can be effective when used appropriately, but they are associated with variable patient compliance and may require extra care to prevent transfer of topical testosterone to partners or children. Long-term injections may offer hypogonadal men a convenient new option."



So whats this mean? It means that with just 1 1000mg dose of injectable Testosterone Undecanoate you can keep mid to high test levels for 12 weeks. It means that with just 4 doses a year you can keep perfectly normal and stable test levels thats what the fuck it means.. Well looking over all the studies and reading everything i can read on the subject. When first starting out using this drug they prescribe 1 1000mg dose to start, then 1 1000mg dose again at the 6 week mark. And then after that its only 1 1000mg dose needed every 12 weeks. But when first starting it you need to take that second 1000mg dose at the 6 week mark but again only when first starting out. I assume to get the blood levels up there quick.

Now has it been studied?
In more than 15 completed and ongoing studies, more than 1,500 patients have been treated with Nebido®, either in studies sponsored by Bayer Schering Pharma or in investigator sponsored studies (ISS).

I will be back with more My lovely little ef buddies!!!
 
Re: If you stay on steroids all the time. Trt,hrt,crusing,or bridging this is a must

Absorption
REANDRON 1000 is an intramuscularly administered depot
preparation of testosterone undecanoate and thus circumvents
the first-pass effect. Following intramuscular injection of
testosterone undecanoate as an oily solution, the compound is
gradually released from the depot and is almost completely
cleaved by serum esterases into testosterone and undecanoic
acid. An increase of serum levels of testosterone above
basal values can already be measured one day after
administration.
Distribution
In two separate studies, mean maximum concentrations of
testosterone of 45 and 24 nmol/L were measured about 7 and 14
days, respectively, after single i.m. administration of 1000
mg of testosterone undecanoate to hypogonadal men. Postmaximum
testosterone levels declined with an estimated halflife
of about 53 days.
In serum of men, about 98% of the circulating testosterone is
bound to sex hormone binding globulin (SHBG) and albumin.
Only the free fraction of testosterone is considered as
biologically active. Following intravenous infusion of
testosterone to elderly men, an apparent volume of
distribution of about 1.0 L/kg was determined.
Metabolism
Testosterone which is generated by ester cleavage from
testosterone undecanoate is metabolised and excreted the same
way as endogenous testosterone. The undecanoic acid is
metabolised by ß-oxidation in the same way as other aliphatic
carboxylic acids.
Elimination
Testosterone undergoes extensive hepatic and extrahepatic
metabolism. After the administration of radiolabelled
testosterone, about 90% of the radioactivity appears in the
urine as glucuronic and sulphuric acid conjugates and 6%
appears in the faeces after undergoing enterohepatic
circulation. Urinary products include androsterone and
etiocholanolone.
Steady State Conditions
Following repeated i.m. injection of 1000 mg testosterone
undecanoate to hypogonadal men using an interval of 10 weeks
between two injections, steady-state conditions were achieved
between the 3rd and the 5th administration. Mean Cmax and Cmin
values of testosterone at steady-state were about 42 and 17
nmol/L, respectively. Post-maximum testosterone levels in
the serum decreased with a half-life of about 90 days, which
corresponds to the release rate from the depot.
CLINICAL TRIALS
There were 4 pharmacokinetic studies, with 3 studies having
open labelled extensions to support the dosage regimen,
efficacy and safety of REANDRON 1000 in the treatment of
hypogonadism. The main pharmacokinetic and efficacy
parameter was serum testosterone within the eugonadal range.
The clinical studies included 72 men treated with REANDRON
1000 (up to a maximum 36 weeks) while 60 men continued
treatment longer term (range 18 –33 months). Initially, the
dosage regimen investigated was 6 weeks between injections
(injected into the gluteal muscle) however this time interval
between injections was found to be too frequent and resulted
in accumulation. An optimal injection interval has not been
defined and injections were administered in the extension
phase of the clinical trials at intervals between 10-12
weeks. The possibility exists that supraphysiological serum
testosterone levels may be attained even at the prescribed
dosage regimen and the dosing interval may need to be
titrated accordingly. Results from the relevant clinical
studies are summarised below.

Research Report No. A00315: This was a pharmacokinetic study
conducted with REANDRON 1000 in 14 hypogonadal men. The
dosage interval between injections was 6 weeks and 4
intramuscular injections were administered. The primary
efficacy parameter was the maintenance of testosterone levels
within the eugonadal range after the 4th injection. Other
secondary parameters investigated were adverse events, local
intramuscular tolerability, status of the prostate and urine
flow and standard clinical chemistry parameters including
serum lipids and PSA. The pharmacokinetic outcomes are
presented below as Figure 1.
Figure 1: Time course of mean serum Testosterone
concentration (measured and net values) with SD during
treatment of 14 hypogonadal patients with
4 x 1000 mg REANDRON 1000 i.m.
 
Re: If you stay on steroids all the time. Trt,hrt,crusing,or bridging this is a must

It was found that at the end of the treatment period, all men
had serum testosterone levels above the lower limit of the
eugonadal range. The 6 week time interval between injections
resulted in accumulation of testosterone suggesting that a
longer time interval between injections was required. The
implication is that serum testosterone levels should be
monitored to determine the optimum interval between
injections. Local tolerability at the injection site (gluteus
medius muscle) was investigated with injection site pain
reported 3 times at the time of injection and 3 times between
injection intervals. Apart from injection site pain and leg
pain associated with the injection, redness and tenderness at
the injections site were also reported.
Research Report No. A01198: This was a comparative study with
REANDRON 1000 and testosterone enanthate (N = 20 per group)
to investigate the efficacy and safety of treatment. REANDRON
1000 was administered intramuscularly at 6 week intervals for
the first 3 injections and then at a 9 week interval while
testosterone enanthate was administered intramuscularly at 3
week intervals over the 30 week study duration. The primary
efficacy variables investigated were erythropoiesis
(hemoglobin, hematocrit) and grip strength, which were
similar between the groups. Multiple secondary and safety
parameters were investigated including serum testosterone
levels and intramuscular tolerability (also see Adverse
Effects). The pharmacokinetic results for both treatment
groups are presented below in Figure 2. The greater
fluctuation in serum testosterone for the group treated with
testosterone enanthate could be due to the longer dosing
interval (3 weeks) between injections.


An extension of this clinical study (Research Report No.
A05965) was allowed whereby all patients (n = 36 initiated
the extension and n = 32 completed the extension phase) were
administered a further 8 intramuscular injections of REANDRON
1000 (84 weeks). The pharmacokinetic results for serum
testosterone in the extension phase are presented in Figure
3.
Figure 2: Mean serum Testosterone levels in 2 treatment
groups of 20 hypogonadal men each before and during
administration of REANDRON 1000 (TU) or Testosterone
enanthate (TE).
 
Re: If you stay on steroids all the time. Trt,hrt,crusing,or bridging this is a must

So essentially needto, the only difference between injecting REANDRON 1000 and Testosterone Enanthate, say, is the convenience of being able to do so once in 12 weeks VS having to do weekly shots. Is that it? Or are there other benefits too?
 
Re: If you stay on steroids all the time. Trt,hrt,crusing,or bridging this is a must

So essentially needto, the only difference between injecting REANDRON 1000 and Testosterone Enanthate, say, is the convenience of being able to do so once in 12 weeks VS having to do weekly shots. Is that it? Or are there other benefits too?

Sounds like its a just a test with a long half life ester. The goal to me sounds like they are just making injectable hrt easier. I dont mind injections but gotta tell ya if I could do HRT with a 10-12 week injection instead of 2x week that would be sweet.
 
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Re: If you stay on steroids all the time. Trt,hrt,crusing,or bridging this is a must

There will still be those idiots that think they need to pin this type of test everyday to "maintain steady blood levels".
 
Re: If you stay on steroids all the time. Trt,hrt,crusing,or bridging this is a must

There may be idiots that think that, but I could see this being awesome for people that want to do 1 inject every 1-2 weeks of the stuff after front loading maybe with sust or test e.

Imagine only needing like 1 shot a week to equal a gram of gear a week. That would be pretty convenient.
 
Re: If you stay on steroids all the time. Trt,hrt,crusing,or bridging this is a must

There will still be those idiots that think they need to pin this type of test everyday to "maintain steady blood levels".

olololololol. Yeah no shit. Peeps will be telling everyone to split up their doses.
 
Re: If you stay on steroids all the time. Trt,hrt,crusing,or bridging this is a must

Hey bros, since we're on the topic of long esters, and I see many people on here commenting on unnecessary frequent injections; what do you bros say about Cypionate? I pin cyp 2 times per week; is this overkill?
 
Re: If you stay on steroids all the time. Trt,hrt,crusing,or bridging this is a must

Hey bros, since we're on the topic of long esters, and I see many people on here commenting on unnecessary frequent injections; what do you bros say about Cypionate? I pin cyp 2 times per week; is this overkill?

i pin testE and testcyp 2X a week .
but you would be fine with 1 time a week
 
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