Why the hell doesnt the FDA approve Nebido?

[ceomuscle58]

nebido.com/

Its a long lasting form of injectable testosterone that has been used in europe since 2004. Check the link out above and the clinical studies on the drug. Im not on testosterone replacement therapy (TRT) yet but the thought of having injections every 3 months beats the hell out of every 5 days.

 

[Frustrated1]

I think it's 8-12 weeks, and you have to take it the first few times every 6 weeks. Now the not so good part. I believe that it's 4cc worth of a shot. Yikes that's a big shot/shots. And it stays in your system for a long time (I can't see where this is a good thing). You see T has a half life of 70 minutes. So injecting something like that that your body can't absorb very well just scares the hell out of me. Some have stated that it's excellent, I've never tried it since I'm in the US where it's not legal. Even if it was, I'm pretty happy with test cyp. so far. I think that total T is also lower than some of us run, just a thought.

So if you are in the fence with HRT... I can tell you that I had issues with it too, until I actually took it. Now I would inject everyday if I had to, fortunately I don't.

 

[J-MO-TECH]

I wouldn't use it if it was available, personally. I have no problem with frequent injections at this point, however it could be useful for someone that simply cant inject any more than every 10-12 weeks?!

 

[Spongy]

my understanding is that Nebido is not approved in the united states as of this time because of a couple adverse reactions to it during clinical trials. the study states that a couple of individuals began coughing and having shortness of breath immediately after injection. There was one instance in the US trial (out of 500 patients), and there were a couple reported in Germany AFTER the drug was approved. The reports in Germany were not as a result of a trial, but rather post marketing. These incidences seem to most likely stem from improper injection. The general thought is that it's more political than anything, given that the EMEA approved it and the FDA, for the most part, is using the EMEA data. The FDA had egg on it's face from a few cases of conflict of interest, etc from other drugs that were approved prematurely so they are most likely wary of approving anything of this nature.

 

[ceomuscle58]

How often are you guys injecting on your prescribed protocols?

 

[Spongy]

E5D currently. Getting bloods done soon and switch to possible E7D or E3D (lower dose) depending on results.

 

[ceomuscle58]

my understanding is that Nebido is not approved in the united states as of this time because of a couple adverse reactions to it during clinical trials. the study states that a couple of individuals began coughing and having shortness of breath immediately after injection. There was one instance in the US trial (out of 500 patients), and there were a couple reported in Germany AFTER the drug was approved. The reports in Germany were not as a result of a trial, but rather post marketing. These incidences seem to most likely stem from improper injection. The general thought is that it's more political than anything, given that the EMEA approved it and the FDA, for the most part, is using the EMEA data. The FDA had egg on it's face from a few cases of conflict of interest, etc from other drugs that were approved prematurely so they are most likely wary of approving anything of this nature.

Looks like its a rare side effect that hasn't killed anyone yet. Maybe two more years and that will make ten years of data then the FDA will most likely approve it.

 

[ceomuscle58]

E5D currently. Getting bloods done soon and switch to possible E7D or E3D (lower dose) depending on results.

Damn that sounds pretty frequent.... Wouldnt you rather inject every 8 weeks if this form of Testosterone gets approved in the US and delivers the same results?

 

[DJ77]

I wouldnt switch, I don't mind the frequent shots at all.
It's hard to change what already works sooo well.

 

[Spongy]

Damn that sounds pretty frequent.... Wouldnt you rather inject every 8 weeks if this form of Testosterone gets approved in the US and delivers the same results?

I wouldn't switch either. Sure, Nebido is probably a better option for those people who are getting 200mg every 2 weeks from their idiot Endos, but there's got to be a swing effect despite it's long ester. I don't mind the frequent injections. In the end, it's all about what works for you though.

 

[Vigilante]

Using it currently and also made a topic on this not so long back.

Im at the 2nd injection stage just had this a few days back.

Before taking the 1st injection my level was 18.2 nmol having been on transdermals for 3 months , 4.5 weeks after having the 1000 mg Nebido my level was 8.7 nmol.

In my case im not sure if im just metabolising it fast or what, but I can say initially I felt better after the 1st shot and same again this time.

Before having this 2nd shot just a few days ago it had actually got to 7 weeks and im guessing it was lower that the 8.7 nmol due to my symptoms which were getting pretty bad, I was feeling constantly pissed up and tired. Since the shot on Monday morning I have slowly started to feel less tired, less zombie like. Im concerned at how long its actually gonna last in me this time..planned next injection is 10 weeks time.

For me id rather do as many do here and thats inject more frequently, im currently waiting to see an endo so ill stay with Nebido until then.

 

[Vigilante]

Damn that sounds pretty frequent.... Wouldnt you rather inject every 8 weeks if this form of Testosterone gets approved in the US and delivers the same results?

It wont deliever the same results as E5D it will deliever results similar to Enanthate which according to the NHS in the Uk is 2-3 weekly. meaning extreme highs and lows.

Nebido the Highs aint meant to be so high and the lows so low but its still a rollercoaster.

 

[RelaxTheBody]

I disagree with the rollercoaster on nebido.

You gents have to stop thinking of it with a test cyp or test e kind of attitude.

The injections are every 10 weeks or so. My endo is well up on testosterone replacement therapy (TRT) and has no issue with giving me test e weekly, but why when you can inject every 10 weeks? Move with the times guys, i know it is not available yet in US but if it was i think it would be crazy not to change.

People are scared to inj at bigger intervals because they are used to weekly test e injections, and argue that more regular injections would keep levels more stable. But again you are thinking with a test e frame of mind, thats like me saying inject test e every day because the levels will be more stable! This is a new ester, it is long acting, the studies have been resounding, there is no rollercoaster. Some people will need the inj a litle earlier yes but its in no way going to cause a crash, these studies have been done over 8 years and there is also strong annecdotal evidence to back this up.

The coughing thing is more than likely some one knicking a vein and some test getting in. Coughing and shortness of breath will occur for a few seconds/minute and then pass. This will happen with test e also.

 

[mlc31]

If Chip and Maximus don't carry it, no thanks.

 

[DJ77]

Relaxthebody, your going to disagree with the only person (viglante) in this thread who's actually taking nebido that it's not a roller coaster? And we would all be crazy not to jump at the chance to use it?

 

[ceomuscle58]

It wont deliever the same results as E5D it will deliever results similar to Enanthate which according to the NHS in the Uk is 2-3 weekly. meaning extreme highs and lows.

Nebido the Highs aint meant to be so high and the lows so low but its still a rollercoaster.

From what i've read this stuff builds up in your system as you get more shots. I saw a graph from a study and i will post it as soon as I find it. I would continue to give it more time if you can. Keep us updated please. Have your labs been looking good thus far?

 

[ceomuscle58]

The graph and one of the studies is in the link below with the effects of long term use on total testosterone levels over a 12 month period.

nebido.com/en/patients/diagnosis-and-treatment/research-news/testosterone-injection-but-not-oral-testosterone-effective-in-men-with-low-testosterone.php

 

[Spongy]

For those of you too lazy to click link

 

[Spongy]

I see problems with this study. First and foremost it does not indicate when the blood tests were taking. For all we know they could have been tested a few days after injection. I understand the concept of a buildup, and the graph certainly indicates that it does build up in the system, but that is only part of the picture. What they're not showing is the fluctuation in levels during that 12 week period of time. All we're getting is little pinpoints of insight into a typical 12 months. A more accurate test of the products ability to produce stable levels would be to get blood drawn every day and see how levels vary. Impractical though...

The other question that needs to be asked is how much testosterone are you actually getting in the 1000mg's? I know Prop is C3, Enan is C7, and Cyp is C8... Undecanoate is C11

 

[Vigilante]

Relaxthebody, your going to disagree with the only person (viglante) in this thread who's actually taking nebido that it's not a roller coaster? And we would all be crazy not to jump at the chance to use it?

For me so far its a rollercoaster thats for sure, infact after 4.5 weeks I was lower than my baseline before I started gels, at 7 weeks I was royally screwed had it gone any longer without I wouldnt have got out of the bed.

Im guessing I shut down my own production now so thats the reason it went so low, I could be on this months waiting for my endo appointment so ill keep everyone updated on my experience with using it.

I do feel so much brighter today, did my gym session and still feel ok, so 4 days after inject my levels seem good enough energy wise. It does not give an instant kick though which im guessing cyp or enan does?