Clinical Study: Older Men and Testosterone

stat1951

New Member
While checking clinical trials and studies going on - or planned, I came across this info:

http://clinicaltrials.gov/ct/show/NCT00119483?order=8

Am I missing some thing here or is that an unbelievably wrong protocol?

QUOTE:
1-year study. First injection at inclusion, second after 6 weeks, the third injection after 16 weeks, the fourth at 28 weeks and the last at 40 weeks. Active treatment is Nebido, 1000 mg testosteron undecanoate, a 4 ml intramuscular depot injection. Schering AS will supply the study with both Nebido and placebo
END QUOTE

6 weeks between injections 1 and 2, then 10 weeks between injections 2 and 3, then 12 weeks between injections 2 and 4 and also between injections 4 and 5???

Using 1000 mg testosterone undecanoate per IM shot?

Am I missing some thing (anything) positive here?


Larry
 
Nebido

Nebido is a new medicine. It is a testosterone esther in a slow releasing oily suspension. It just came out last year. A this time, some of the hypogonadal people I know are just starting to use it. They are sharing their experiences in an other forum. The experiences are not that positive all in all.

You can get some info on the manufacturer's website.

http://www.get-back-on-track.com/en/consumer/00_meta/04_produkte/c_con_0004_03_00.php

There are a lot of clinical studies on the product available in PubMed. If you are interested, you can look there. I have read some (sponsored studies) and i was amazed how biased they were (in favor of the sponsor).

My advise: wait and see. Do not start using this before you have heard some experiences from other users...
 
Another link on Nebido.

http://www.docguide.com/news/content.nsf/news/8525697700573E1885256ECB004A4A29
 
RE: Nebido

I checked their site at:

http://www.get-back-on-track.com/en/consumer/00_meta/04_produkte/c_con_0004_03_0\
0.php

And I immediately noted this comment:

QUOTE:
Patients value the consistent, reliable efficacy and the long duration
of effect. Nebido liberates patients from the burden of approximately
20 injections of conventional testosterone therapy per year. In
contrast, only four injections of Nebido are required per year.
END QUOTE

One shot every 2 weeks would be 26 shots over the course of the year,
so they are perceiving state-of-the-art current therapy as being even
less than that (i.e., 20 shots per year).

Now readers of this board (and other boards) know that the previous
standard of one IM shot every two weeks may have been better than one
shot every three weeks or one shot every four weeks, but that it still
resulted in too much of a roller-coaster effect. Therefore more
advanced TRT doctors went to one IM shot weekly (100 mg usually).

Then I checked out more specifics at:

http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=15661

QUOTE:
Each ml solution for injection contains 250 mg testosterone
undecanoate corresponding to 157.9 mg testosterone. Each ampoule with
4 ml solution for injection contains 1000 mg testosterone undecanoate.
END QUOTE

So each IM shot given provides 632mg of testosterone (157.9 rounded
off to 158 times four).

QUOTE:
One ampoule of Nebido (corresponding to 1000 mg testosterone
undecanoate) is injected every 10 to 14 weeks. Injections with this
frequency are capable of maintaining sufficient testosterone levels
and do not lead to accumulation.
END QUOTE

So that means that this 632 mg of testosterone is expected to last for
a 10 - 14 week time period. That breaks down to 63mg per week for 10
weeks - and only 45 mg per week for 14 weeks!

That strong of a dose "should" give you a pretty good range of T once
it starts leaching into the blood stream (maybe even considerably too
high initially?), but then what about towards the end of each 10 - 14
week cycle? Okay, maybe there's something "special" in their formula
that keep the T "leaching into the bloodstream" at a more consistent
rate and not heavy at first and then less as time goes on???

Nope.

QUOTE:
The injection interval should be within the recommended range of 10 to
14 weeks. Careful monitoring of serum testosterone levels is required
during maintenance of treatment. It is advisable to measure
testosterone serum levels regularly. Measurements should be performed
at the end of an injection interval and clinical symptoms considered.
These serum levels should be within the lower third of the normal range.
END QUOTE

Note the last sentence. The manufacturer fully anticipates that the
TRT patient's levels will have fallen within the bottom third of the
normal range towards the end of the cycle.

Do they understand - even slightly - that this is the dreaded
"roller-coaster effect" that was what caused TRT patients to go to
more frequent IM shots instead of the less frequent IM shots that were
being done over the last couple of decades?

Then on top of that is their really low dosages of T being delivered
(and that's averaged out... the actual delivery would start out
strong and by the last 2 - 3 weeks would be down to a trickle).

Talk about a "giant leap".....

Backwards!

More:

http://www.androids.org.uk/gels.html
QUOTE
Daily treatment options, enable fast response to drug reaction issues,
whereas, starting a patient on a long-acting drug, consigns them to
the effects of that drug, for the duration. In this case,that period
would be six to twelve weeks. Perhaps it is a matter of cost?
A scan of the prescribing sheet reveals overdose proportions (37
nmol/l) will be reached during the six week treatment cycle.
END QUOTE

http://www.calibula.net/news/

http://www.endocrine-abstracts.org/ea/0007/ea0007p192.htm
(only ten test subjects)

Strange topic page, but good answers on various TRT options:

http://www.answers.com/topic/hormone-replacement-therapy-trans
QUOTE:
'Depot' drug formulations are created by mixing a substance with the
drug that slows its release and prolongs the action of the drug. The
two primarily used forms in the US are the testosterone esters
testosterone cypionate (Depo-Testosterone) and testosterone enanthate
(Delatestryl) which are almost interchangeable. Enanthate is purported
to be slightly better with respect to even testosterone release, but
this is probably more of a concern for body-builders who abuse the
drugs at higher doses (250-1000 mg/week) than the replacement doses
used by transgender men (50-100mg/week.) They are mixed with different
oils, so some individuals may tolerate one better than the other.
Enanthate costs more than cypionate and is more typically the one
prescribed for hypogonadal males in the US. Cypionate is more popular
in the US than elsewhere (especially amongst bodybuilders.) Other
formulations exist but are more difficult to come by in the US.
Sustanon is a formulation that mixes shorter acting and longer acting
testosterone preparations that gives more even levels of testosterone
with injections given every three weeks. The adverse side effects of
injected testosterone esters are generally associated with high peak
levels in the first few days after an injection. Some side effects may
be ameliorated by using a shorter dosing interval (weekly or every ten
days instead of twice monthly with enanthate or cypionate.) 100 mg
weekly gives a much lower peak level of testosterone than does 200 mg
every two weeks, while still maintaining the same total dose of
androgen. This benefit must be weighed against the discomfort and
inconvenience of doubling the number of injections. Injected
testosterone esters should be started at a low dose and titrated
upwards based on trough levels (blood levels drawn just before your
next shot.) A trough level of 500 ng/dl is sought. (Normal range for a
biological male is 290 to 900 ng/dl.) A newer form of injected
testosterone, Nebido (testosterone undecanoate in oil) provides better
testosterone delivery with much less variation outside the normal male
range, with injections required only every twelve weeks. However, each
quarterly dose requires injection of 4ml which may require multiple
simultaneous injections. Nebido is also much more expensive...
END QUOTE

Nebido is just a marketing ploy to dress up an existing form of
testosterone (testosterone undecanoate) in a different suit of clothes
and market it as a "much more expensive" (but "supposedly" improved)
version.

The manufacturers know - going into the marketing - that users are
going to have plummetting T levels toward the end of a cycle, but
shrug it off that as long as it's still in the "normal range" (even if
just barely low normal for the last 2 - 4 weeks!), that you're
"okay"... and look at all of the inconvenience you'll save by only
doing four shots a year!!! (Joke!)

Larry

Also if you go to http://www.globalandropause.com/forum/disc6_frm.htm and talk to some of the men on Nebido they have reported it does not work very well... they report feeling good the first 2 or 3 week then it's down hill.
 
Personally, I plan on staying away from Nebido as far as possible. Until I get the chance to set up a program with SWALE, I'm hanging in there with a local doc who is "not quite" in the dark ages completely... but still thinks that state-of-the-art is IM shots of 200 mg given once every two weeks. No thanks on that roller-coaster ride. And I shudder to think of what the roller-coaster effect with this Nebido will be!
 
I wonder why thye gave the study such a goofy name that does not even have anything to do with the actual topic?
 
I re-checked the link and just noted that the study is being conducted by a hospital in northern Norway.

Maybe they figured that if they got enough participants (looking for 200 men) who were elderly males (60 - 80 yrs old is requirement) who have been hypogonadal for some years that even something this horrible will be "better than nothing"... and then the researchers (paid for by the makers of Nebido) can write up a glowing clinical study that the FDA can then use to push across approval of Nebido???

Just my humble opinion of course!

Larry
 
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