:HRT therapy Nebido:

[marcus300]

Ive recently had a few questions regarding the new HRT therapy Nebido whats available, hopefully this thread will answer some of those questions I keep getting asked. Nebido is a 1000mgs 4ml amp of testosterone undecanoate set in castor oil.

When I was put on HRT a few yrs ago my Endocrinologist tried various therapies to bring my Testosterone levels back up to a level were I was feeling better, eventually we got this from Test E which was shot every 12-14 days, my life completely changed and the demons what I use to fight everyday finally went.

Over 18 months ago my Endocrinologist started to tell me about this new therapy what he wanted to try because it was claiming remarkable results, he quoted me study after study and told me this product is getting alot of headline news and many Endo's are talking about how this kind of application will out date every other method when its available world-wide.

i've been using this product now for over 12 months and ive found it to be far superior than any other HRT therapy i've ever used. My blood values are more stable than ive ever had and i feel like 21yrs old again,

There is a loading phase for the first 6 wks and then its one injection every 12 wks or in some case's 10 wks depending on how your BW comes back and what protocol your doctor use's.It has a very long half life which is why your doing a loading phase to bring blood values up and then a maintenance dose to keep them there, at first I wasn't convinced but after using it and reading the studies I cant recommend this product highly enough, its simply remarkable and definitely worth trying.

Below are some studies what have been done which make excellent reading, there are many more available but here a just a few:

2.5 yrs study- http://jcem.endojournals.org/cgi/con...ull/89/11/5429

8yrs study- http://www.agingmale2006.com/abstrac...onadal_men.asp

9 yrs study- Agingmale2006.com

http://www.expert-reviews.com/doi/ab...750708.3.6.709

http://www.drugs.com/nda/nebido_070828.html

[zaggahamma]

thanks marcus

[marcus300]

thanks marcus

I know its not yet available in a few Countries but its worth looking into when it is, I have 4 injection a year which is amazing to what I use to have.

[Merc.]

I am on HRT also ( for many years ) .. I am using 100 mg of cyp EW ( which still has my total test - as well as free test ) levels on the high end ( of begin in range)..


I have been debating using this for quite some time ( was also looking into pellets ).. I think I am going to give the Nebido a try ..




Merc.

[marcus300]

I am on HRT also ( for many years ) .. I am using 100 mg of cyp EW ( which still has my total test - as well as free test ) levels on the high end ( of begin in range)..


I have been debating using this for quite some time ( was also looking into pellets ).. I think I am going to give the Nebido a try ..




Merc.

What are your levels at that dose Merc?

Pellets?? are you talking about those time released pellets or is this something else?

[Merc.]

What are your levels at that dose Merc?

Pellets?? are you talking about those time released pellets or is this something else?

Yea the time released test pellets ..

My latest bloodwork my total test levels were 987 Nanograms ( ng/DL ) ..

My free test was at 29.7 pg/mL ( the refrence ranges at the lab I use for free test is 8.7 - 25.1 pg/mL ) ...


Merc.

[marcus300]

Yea the time released test pellets ..

My latest bloodwork my total test levels were 987 Nanograms ( ng/DL ) ..

My free test was at 29.7 pg/mL ( the refrence ranges at the lab I use for free test is 8.7 - 25.1 pg/mL ) ...


Merc.

Yes I looked into these many yrs ago when they were only available for women and there was talk about using it for men, I am sure i read reports regarding the delivery of the drug wasnt consistent and there were massive fluctuations within the blood and there were problems with judging when the drug needed re-implanting, I've never tried them but I wouldnt swap anything for nebido, I believe its breaking all records but not sure if its available in the US yet, but worth a try when it is

[Merc.]

Yes I looked into these many yrs ago when they were only available for women and there was talk about using it for men, I am sure i read reports regarding the delivery of the drug wasnt consistent and there were massive fluctuations within the blood and there were problems with judging when the drug needed re-implanting, I've never tried them but I wouldnt swap anything for nebido, I believe its breaking all records but not sure if its available in the US yet, but worth a try when it is

Yea not sure if it is in the USA yet .. I do kinda remember reading that they have extend the release date a few more months ..( I think they might have said it will be available in Nov or maybe it was Dec in the USA )..

When I checked a while back the FDA had concern about a couple of cases in Europe where the patient experienced a cough ( similar to tren cough ) after injecting the 4 ML of Nebido ..

I know they ( the FDA) were testing a 3ML ( 750 mg ) version of Nebido for the USA ( instead of the 1000 mg 4 ML like you have in Europe ).. but I havent checked recently if they plan on using a 3 ml ( 750 mg) version for the USA or the 4 ML like in Euorpe ...



Merc.

[marcus300]

Yea not sure if it is in the USA yet .. I do kinda remember reading that they have extend the release date a few more months ..( I think they might have said it will be available in Nov or maybe it was Dec in the USA )..

When I checked a while back the FDA had concern about a couple of cases in Europe where the patient experienced a cough ( similar to tren cough ) after injecting the 4 ML of Nebido ..

I know they ( the FDA) were testing a 3ML ( 750 mg ) version of Nebido for the USA ( instead of the 1000 mg 4 ML like you have in Europe ).. but I havent checked recently if they plan on using a 3 ml ( 750 mg) version for the USA or the 4 ML like in Euorpe ...



Merc.

I know the release date is soon or from what ive read, but I didnt see anything about a smaller dose, there have been studies going on for 8 and 9yrs with 1000mgs and ive not seen anything regarding a smaller dose.

I think if people are really happy with their HRT therapy treatment they should stick with it, but with less injections and better stable levels in the mid to high end I guess it will make a few try it.

[Merc.]

I know the release date is soon or from what ive read, but I didnt see anything about a smaller dose, there have been studies going on for 8 and 9yrs with 1000mgs and ive not seen anything regarding a smaller dose.

I think if people are really happy with their HRT therapy treatment they should stick with it, but with less injections and better stable levels in the mid to high end I guess it will make a few try it.

Here you go Marcus ...


Company Announces Revised Operating Plan to Respond to Nebido Delay

LEXINGTON, Mass., June 30, 2008 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Nebido related to a New Drug Application (NDA) submitted to the FDA in August 2007. The letter, received on June 27, 2008, indicated that the application may be approved if the Company is able to adequately respond to certain clinical deficiencies related to the product. The letter generally confirmed the Company's previously-announced indications from the FDA based on telephone discussions.

The FDA has expressed a concern about a relatively small number of patients in European post-marketing use who have experienced respiratory symptoms immediately following the intramuscular injection of Nebido 1000 mg, 4 cc injection volume, (versus the 750 mg, 3 cc injection volume used in the United States). The Company believes and the FDA concurs that the reaction is likely the result of a small amount of the oily solution immediately entering the vascular system from the injection site, a known, rare complication of oil-based depot injections.

The phenomenon is characterized by short-term reactions involving an urge to cough, coughing episodes or a shortness of breath. In rare cases the reaction has been classified as serious or the patient experiences other symptoms such as dizziness, flushing or fainting. In the Company's U.S. clinical trials of Nebido 750 mg (3 cc injection volume), the proposed dose in the U.S., there was a single, mild, non-serious case of oil-based cough observed. In addition, the FDA believes that four cases in the European post-marketing experience may have an allergic, anaphylactoid component, although the Company believes these cases were improperly classified and represent the same oil-based phenomenon.

The FDA has requested the Company address these clinical deficiencies by providing detailed safety information from clinical studies to determine the precise incidence of serious post-injection oil-based reactions and allergic reactions. Specifically, the FDA has requested follow-up data from the on-going U.S. and European studies in which patients are being treated with Nebido on an extended basis. A majority of these trials are scheduled to be completed within twelve months. The FDA stated that depending on the findings, the number of subjects and the number of injections of testosterone undecanoate from the studies listed above, the safety database may need to include data from additional clinical studies. They have requested that the Company propose the size of the safety database (i.e., total number of subjects exposed to testosterone undecanoate intramuscular injection and total number of injections) and the rationale for the size of the proposed safety database.

FDA has also requested the Company provide a plan to minimize the risks associated with the clinical use of testosterone undecanoate intramuscular injection, namely, to reduce the incidence and/or severity of the serious oil-based reactions and has requested certain in vitro and skin-testing data to exclude an allergic component to the drug or some of its excipients.

Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus stated, "We believe that Nebido is a safe and effective drug for its intended use and continue to be disappointed that the FDA was not willing to approve the drug at this time with adequate labeling of the oil-based reactions and how to minimize them with proper injection technique. However, we are encouraged that this approvable letter provides a road map for the product's eventual approval. We will work with the FDA and our partner, Bayer Schering Pharma AG, to respond to the approvable letter and devise a plan to address the deficiencies. While the FDA has not specifically requested additional clinical studies, we believe that an additional study will likely be required to demonstrate that Nebido 750 mg (3 cc volume) administered with careful and proper intramuscular injection technique, has an acceptably low incidence of oil-based reactions to gain approval. In addition, we are pleased that FDA has provided guidance on how we can demonstrate that the product does not cause allergic reactions. We hope to be able to articulate a development plan to address FDA concerns within the next few months, and for now are maintaining our previous guidance that it may take the Company approximately 18 months to re-submit the revised NDA. We will communicate specific guidance on clinical plans and timelines when they are available."

Link to above copy and paste .. http://www.drugs.com/nda/nebido_080630.html


And Heres info on the release date ..


Testosterone drug Nebido to treat low sexual libido in men delayed in US


Thursday, September 3, 2009, 17:21

Nebido, a testosterone drug for men with low sexual drive from Endo Pharma, has been delayed for approval in US.

Testosterone treatment Nebido’s review date has been extended by three months by the U.S. Food and Drug Administration. USFDA, however, did not request for additional data, said Endo Pharmaceuticals Holdings Inc in an official release.

US FDA extended the review date for Nebido from Sept. 2 to Dec. 2 and has stated that it needs more time to complete its review of the application and finalize the risk evaluation and mitigation strategy (REMS) for the long acting version undecanoate of the testosterone product.

Nebido is already approved outside the United States as a treatment for hypogonadism or low testosterone .

Nebido, discovered and developed by Bayer Schering Pharma AG, Germany, has subsequently been approved in 86 countries worldwide and is available in more than 50 countries across Europe, Asia Pacific and Latin America.

“Our goal is to make this significant new treatment option available to the millions of men in the U.S. suffering from low testosterone,” stated David Holveck, president and chief executive officer of Endo Pharmaceuticals.

Nebido was licensed by Bayer Schering Pharma to Indevus Pharmaceuticals, a company that Endo acquired earlier this year.


And heres the link to that info

http://www.dancewithshadows.com/pill...delayed-in-us/



I cant wait ... I am starting to get excited now.. I am definitely going to give it a try ... Thanks for your info on it ( i was wanting to get some feedback from someone who has use it ...


Merc.

[marcus300]

The coughing can occur from any type of injection if you nick a vein lol, kind of funny that one.

Its a shame if the US are going to go with the 750mgs injection instead of the 1000mgs one because of all the remarkable studies what have come through with the bigger dose, but I do feel it will still break results in the field of HRT, i know a few guys who have started this treatment in the UK who are very pleased with it.

Guess time will tell

[Merc.]

The coughing can occur from any type of injection if you nick a vein lol, kind of funny that one.

Its a shame if the US are going to go with the 750mgs injection instead of the 1000mgs one because of all the remarkable studies what have come through with the bigger dose, but I do feel it will still break results in the field of HRT, i know a few guys who have started this treatment in the UK who are very pleased with it.

Guess time will tell

Yea I thought that was funny also ( the cough part)..

I hope they go with the 1000 mg dose in the USA as well.. I mean like you said .. all the studies ( for many years are done with that 1000mg dose )..



Merc.

[marcus300]

Yea I thought that was funny also ( the cough part)..

I hope they go with the 1000 mg dose in the USA as well.. I mean like you said .. all the studies ( for many years are done with that 1000mg dose )..



Merc.

With 4 injection every year, half the planet will be on it sooooon

[Merc.]

With 4 injection every year, half the planet will be on it sooooon

I agree.. Screw this dam weekly injection for HRT shit.....



Merc.

[flatscat]

I agree.. Screw this dam weekly injection for HRT shit.....



Merc.

I'll throw in with you on that one -

Flats

[Merc.]

I'll throw in with you on that one -

Flats

Yea cant wait until Dec .. so i only have to do 4 shots per year.( SWEET)






Merc.

[zaggahamma]

as inexpensive as my cyp??????????????

[Merc.]

Sup Jpk

Not sure what $ is going be in the USA...



Merc.

[zaggahamma]

Sup Jpk

Not sure what $ is going be in the USA...



Merc.

finally got one by

[kesam1]

My experience with Nebido is that unless injected at 8 week intervals it can cause a rollercoaster and even then I prefer to split the 4cc into 4 different injections and shoot every 2 weeks.

[marcus300]

My experience with Nebido is that unless injected at 8 week intervals it can cause a rollercoaster and even then I prefer to split the 4cc into 4 different injections and shoot every 2 weeks.

Did you do the loading phase for the first 6 wks?

Did your have bloodwork done?

I know including myself around 5 people who are using Nebido and 4 of us are doing 1 every 12 wks and one is doing 1 every 10 wks, strange your having a rollercoast ride unless you didnt load correctly, but if for some reason your different than most 8 wks is still great but your the only one ive seen under 10 wks.

[Vettester]

Wow, this is very interesting! I'm going to talk to my HRT team and see if this can be implemented into my program for next year. Thanks for sharing this, Marcus.

[marcus300]

http://www.fiercebiotech.com/node/7168

[warchild]

aww fvck, i forgot to ask my trt doc about nebido...how would it work if i want to do a cycle of test with nebido???

[Charlie6]

yea bump for this question ^^

[marcus300]

aww fvck, i forgot to ask my trt doc about nebido...how would it work if i want to do a cycle of test with nebido???

Guess there are two ways to go about it and it would depend when you started the cycle because of the long ester I would cycle on and off a course while maintaining the HRT dose, starting a cycle at the start of a injection of HRT that will give you 3 months to finish the cycle before the nexted shot but you would have to take in consideration the HRT dose when planning the cycle, or you could not take the next shot of HRT and start a cycle and finish it when your ready for the next HRT injection in 12 wks, which ever suits you better.

[zaggahamma]

Guess there are two ways to go about it and it would depend when you started the cycle because of the long ester I would cycle on and off a course while maintaining the HRT dose, starting a cycle at the start of a injection of HRT that will give you 3 months to finish the cycle before the nexted shot but you would have to take in consideration the HRT dose when planning the cycle, or you could not take the next shot of HRT and start a cycle and finish it when your ready for the next HRT injection in 12 wks, which ever suits you better.

i would just jab more when i felt like it

[kesam1]

Did you do the loading phase for the first 6 wks?

Did your have bloodwork done?

I know including myself around 5 people who are using Nebido and 4 of us are doing 1 every 12 wks and one is doing 1 every 10 wks, strange your having a rollercoast ride unless you didnt load correctly, but if for some reason your different than most 8 wks is still great but your the only one ive seen under 10 wks.

Load was carried out ie 2nd jab at six weeks, levels prior to week 12 injection were 19 Doc prescribed next injections (self administered) at 9 week intervals but was happy to let me go to 8 if felt the need. I had my third full 4ml jab at week 12 (used this as another load) and have since done 1ml every 2 weeks. Started on liquidex 0.25 eod and crashed my e2 (not tested) I have only just got the liquidex dosage where i feel good at 0.25ew.

I feel the 12week load inj I did was unnecessary and stupid of me but the 1ml e2w is now feeling lovely and now on week 18 the 2nd load from week 12 should be dying out and I hope not so much E2 trouble.

I love the nebido and 8 to 9 weeks seems correct for me but splitting it I feel will stop the large rise in t and e2 post injection. imo

[ottomaddox]

I'd pay anything to not have to inject every 10 days.

[marcus300]

http://emc.medicines.org.uk/document...cumentId=15661

[BREW-MAN]

i got this on the black market,whoop whoop.

[FlyingIllini]

Anyone see a blood work profile over the 12 wks to see how the blood levels of testosterone vary ?

[marcus300]

Anyone see a blood work profile over the 12 wks to see how the blood levels of testosterone vary ?

Read the studies what ive posted, there are many more and all with detailed BW, some of the studies were taken over 2.5yrs,8yrs and 9 yrs

[BJJ]

Very interesting thread.

[Sharky72]

Anybody have a update on this? Thanks

[marcus300]

Anybody have a update on this? Thanks

Update on what exactly?

[lovbyts]

I think he is/was referring to is it available in the US yet.

[marcus300]

The drug is approved in 86 countries but recently in the US its come across a delay due to the FDA having concerns about post injection anaphylactic reactions as well as pulmonary oil mircoembolisms, further studies are taking place but Schering stated it will be approved but some opposition have delayed the launch.

[martyjack]

Marcus....you seem to have alot of experience with Nebido! I just recently started Nebido....I take my second injection in a week! I just want to see if you have estrogen problems....do you take arimidex and how often? Do you include any HCG for testicle shrinkage....if so how often? Also my semen levels and morning wood are non-existant. I have been on HRT for about six years...so these symtoms were already there. Can you please give any advice? Thanks

[marcus300]

Marcus....you seem to have alot of experience with Nebido! I just recently started Nebido....I take my second injection in a week! I just want to see if you have estrogen problems....do you take arimidex and how often? Do you include any HCG for testicle shrinkage....if so how often? Also my semen levels and morning wood are non-existant. I have been on HRT for about six years...so these symtoms were already there. Can you please give any advice? Thanks

How are you taking your Nebido? what is your frontload?

I dont take anything for estrogen related sides because I dont suffer any while on Nebido, but if your prone I would keep something to hand like a-dex.

I have done HCG to keep my testicles full for cosmetic purposes but I dont anymore because it doesnt bother me having some shrinkage,

While on HRT you semen levels do go down alot or the amount of fluid does, have you had any bloodwork done to see what levels you are, how is your sex drive? do you have erection problems? what was your previous HRT protocol