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Another Testosterone Question
Nov 9, 2011

Hi Nelson,

Firstly thank you for all the valuable information that you give us all the time. It is really appreciated by us reading the forums.

I have all the "classic symptoms" of low sex drive, fatigue, lack of mental focus, low mood etc. as per you recent answer to another question, so being a 45 year old man I decided to get some blood tests done as I have been really struggling with this for the most part of the year. BTW I am on Viramune and Truvada once a day since July 2005.

My thyroid is OK as is my prostrate but these are my testosterone results.

Total Testosterone - 9.9 (Range 8.0-27.1 nmol/l) SHBG (Roche) 45.2 (Range 11.4-52.3 nmol/l) Free Testosterone Calculated 159 (Range 180-536 nmol/l)

I am not very happy at all with these results so my doctor wants to give me a ampule shot of Nebido. He says it has helped his other patients well and should do so for me as well. It usually lasts between 8 to 10 weeks.

Is this good advice or would you recommend something else in my situation because what happens when it wears off.Do I need to go back for another shot and if so is this a lifetime treatment ? What are some of the side effects I need to worry about ?

Many thanks for all your help.

Paul (Johannesburg, South Africa)

Response from Mr. Vergel

Paul:

You have hypogonadism (testosterone deficiency). Nebido is an a long acting testosterone injection not approved yet in the United States, but approved in most countries. Yes, testosterone replacement therapy usually is a life long commitment. I wish I could tell you otherwise.

This is an excerpt from my book Testosterone: A Man's Guide (ordering info on TestosteroneWisdom.com)

Testosterone undecanoate injections are known as the brand name Nebido around the world. In the United States it will be called Aveed. Aveed is currently under review for approval by the FDA. This ester may stay longer in your system so that less frequent injections may be needed. The injection is usually given once every 10 to 14 weeks, though the frequency will depend on your individual testosterone levels. After your first injection you may be asked to come back for another injection at week six. For use in the United States, the company claims that only five injections a year are needed (compared to 48 injections per year for a 100 mg per week regimen). In other countries, a large injection dose of 1000 mg are allowed. The FDA did not allow the manufacturer to use this dose in studies done in this country due to fears of side effects.

In an open-label study which enrolled 130 hypogonadal men with blood total testosterone levels below 300 ng/dL at study entry, Aveed 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 injections and 94 percent of them had total testosterone from 300 to 1,000 nanograms/ml through the entire study.

After Nebido was approved in Europe a small number of European patients experienced respiratory symptoms immediately following an intramuscular injection of 1000 mg in a 4 cc injection volume, (versus the 750 mg, 3 cc injection volume used in the United States). The makers of Nebido believe, 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. This known yet uncommon complication of oil-based depot injections may be related to inappropriate injection technique or site.

The problem is characterized by short-term reactions involving an urge to cough or a shortness of breath. In some rare cases the reaction had been classified as serious or the patient had experienced other symptoms such as dizziness, flushing or fainting. In 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 coughing.

The U.S. manufacturer, Endo Pharmaceuticals, is gathering data to address concerns about the respiratory symptoms. It is not known how much longer it will take the get this product approved in the United States as of June 2010. And even if it gets approved, it may not be widely available for people to buy through private health insurance if the company decides to price it as high as gels.

PERSONAL COMMENT: I have used testosterone enanthate, cypionate, and Sustanon 250. I cannot say I can tell the difference in the way I felt. I also tried one injection of Nebido in Mexico. After a big injection of the recommended dose of 1,000 mg, my testosterone blood levels remained above 450 ng/ml for four and a half months; my mood and stamina remained very good throughout. It was nice not having to worry about remembering to inject every week.

I hope this helps!

Nelson Vergel



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