Subcutaneous vs intramuscular testosterone study- ( abraham morgentaler )

Thread starter #1
Sponsor- Men's Health Boston (March 2017-March 2018)

Summary
In this randomized, cross‐over study 20 subjects who are undergoing testosterone (T) therapy for the treatment of T deficiency will receive both subcutaneous testosterone therapy and intramuscular testosterone therapy. One group will receive a SQ injection followed by an IM injection and one group will receive an IM injection followed by a SQ injection. The primary objective of this study is to measure testosterone concentration in men after these two treatment routes and determine if there are any significant differences due to modes of administration. Endpoints will include total serum testosterone and calculated free testosterone. A questionnaire will also be administered to assess overall patient experience with each route of administration

Will be interesting to see results once study is completed https://www.smartpatients.com/trials/NCT03091348
 
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#2
Methodolgy seem a bit under thought out. At least what's written is unclear.

"One group will receive a SQ injection followed by an IM injection and one group will receive an IM injection followed by a SQ injection. "

So this implies basing data on single doses and not accounting for half life and reaching stable state on either method.

But further in the info it states 4 weeks. It is unclear whether they are administering a single injection then measuring at weeks out which seems ludicrous, or keeping subjects on consistent dosing for 4 weeks. But then we know that based on 1/2 life, they really should be testing after 6 weeks of consistent therapy using one method.

How about IM for 6 weeks then measure, then switch to SubQ for 6 weeks and measure... and vice versa?
 
Thread starter #3
Methodolgy seem a bit under thought out. At least what's written is unclear.

"One group will receive a SQ injection followed by an IM injection and one group will receive an IM injection followed by a SQ injection. "

So this implies basing data on single doses and not accounting for half life and reaching stable state on either method.

But further in the info it states 4 weeks. It is unclear whether they are administering a single injection then measuring at weeks out which seems ludicrous, or keeping subjects on consistent dosing for 4 weeks. But then we know that based on 1/2 life, they really should be testing after 6 weeks of consistent therapy using one method.

How about IM for 6 weeks then measure, then switch to SubQ for 6 weeks and measure... and vice versa?
It would make more sense that one group will start on subcutaneous (?)mg/week for 4 weeks and than switch over to im (?) mg/week for 4 weeks and the other group vice versa as there would be no point in one injection whether sub-q or im as 4 weeks after injection testosterone levels would be crashed.

It is stated that endpoint measurements (primary outcomes) for changes in tt and calculated free t is 4 weeks and endpoint measurements (secondary) for changes in estradiol/lh/fsh/shbg/psa/hematocrit/low testosterone questionnaire responses and international prostate symptom scores is 4 weeks.

I would think results for the endpoint measurements would be skewed if each group only was injected once sub-q than im and vice versa.

You are right that a longer study of each injection method would be better 6-8 weeks and specific details of the study are vague.

Morgentaler is well respected in the field of trt so I would think he knows what he is doing!
 
Thread starter #8
Any update on this trial? Can't seem to find much info.

Says Actual Study Completion Date : January 2, 2018
March 2018 was listed as the completion date of the study and once completed it may take some time before it is reviewed/published.
 
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