Oral testosterone. Who's on it?

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Who here is on some form of oral. jatenzo/Kyzatrex?
What has it done for you?
What are your numbers?
Has RBC increases been as much as a problem for you on the orals?
How is your liver tests?

Thank you
 
Defy Medical TRT clinic doctor
I’m the only regular forum member on oral testosterone, Jatenzo @237 mg twice daily, which is the recommended starting dosage.

The last total testosterone was at 401 ng/dL at nine hours, well past my midpoint (6 hours) which is when you’re supposed to test.

That would put my true midpoint in the 600-700 range. I’m noticing higher levels on the carnivore diet probably related to eating foods high in fat which is what’s required to absorb Jatenzo.

I had taken a massive dose of iron supplements for three years when I didn’t need it, so my CBC and red blood cells are still declining.

I won’t know where my levels will end up for a couple of months. As for what oral testosterone has done for me, just click on the link below and see for yourself.

Liver tests are all normal, on the lower end.
 
Last edited:
I am taking Kizatrex for 3 weeks. So far, so good.

What dose?
 
I am taking Kizatrex for 3 weeks. So far, so good.


Glad to hear.

Just a matter of time before you gave this a go LOL!

3 weeks in well past steady-state hope things turn out for the best.

Would be interesting to see where your TT, FT, and DHT sit let alone what impact it has on your SHBG and hematocrit!

Left out estradiol as I know you mentioned that you always struggled with low e2 and had added it to your protocol to bring your levels up.
 
No, men on injections are going to be more likely to experience high hematocrit and hemoglobin and topicals and orals are the least likely to experience these issues.

Only a very small percentage of men in the oral testosterone trials experienced secondary erythrocytosis.

You stated:

If you want to rid yourself of having problems with secondary erythrocytosis, thus forcing donation and crashing of ferritin levels, the newer oral testosterone options, Jatenzo, Kyzatrex and Orlando in the clinical trials had zero cases of secondary erythrocytosis due to the PK profiles!




Glad this post sunk in your dome!

 
Who here is on some form of oral. jatenzo/Kyzatrex?
What has it done for you?
What are your numbers?
Has RBC increases been as much as a problem for you on the orals?
How is your liver tests?

Thank you


post #2





*mean increases from baseline in hematocrit were observed in both treatment groups at each study visit but remained within the normal range in most men (97% oral TU; 100% topical T).

*Shifts from normal hematocrit values at baseline to above the normal range were observed in 3% of oral TU patients at the final visit, compared with none of the topical T patients






*The formulations with the lowest risk of erythrocytosis are intranasal testosterone (0-2%) and oral testosterone (0.03%).3 A phase 3 clinical trial of testosterone undecanoate (Jatenzo) reported 4.8% patients experienced an increase in hematocrit, although not severe enough to warrant therapy discontinuation.2





      • Risk/rate of erythrocytosis according to formulation:
        • Intramuscular injections – 40%
        • Subcutaneous pellets – 35%
        • Transdermal – 15%
        • Androgel – 3%
        • Intranasal testosterone – 0–2%
        • Oral testosterone – 0.03%





Looking Ahead

The market now boasts a wide range of commercially available options, including novel oral formulations with favorable safety profiles and no liver toxicity concerns. However, it remains crucial to monitor blood pressure in patients prescribed oral TRT.




1717202501934.png





1717202560860.png





 
Is there a Rx native testosterone that ins. Will cover?

No.

As of now there is no oral native testosterone that has been licensed for TRT.

Diurnal has already developed a novel oral NT formulation, research is still ongoing but I have not heard any updates since 2022 regarding the Phase 2 study.





*In the 1970s, a micronized form of free testosterone was demonstrated to be absorbed in hypogonadal men but absorption was not reliable enough to progress as therapy (14). Further research, particularly by Amory and coworkers, showed that native testosterone administered as a suspension in oil, provided potentially therapeutic levels of testosterone in healthy men (15), and combined with 5αreductase inhibitors provided physiological testosterone levels both in the fasted and fed state (16). Native testosterone is practically insoluble in water and in fatty oil vehicles (22), and the challenge has been to develop a solution formulation that contains sufficient testosterone concentration to provide reproducible physiological testosterone levels in hypogonadal men. Building upon the previous observations, we have developed a lipidic solution formulation of native testosterone and have tested it in dogs and humans in the fasted and fed state.

*Diurnal’s DITEST™ product is a formulation of unmodified testosterone that seeks to avoid the issues of poor bioavailability by using a proprietary, oil-based excipient mixture. It has not been reported on how this excipient mixture avoids the issue of first-pass metabolism, but Diurnal has reported results from a Phase I study (n=25, 24 completed treatment) that showed similar pharmacological parameters to testosterone undecanoate, but without the food effect.





Discussion

We have developed an oral lipidic formulation of native testosterone in a solution that provides physiological levels of testosterone and DHT when taken with or without food. The preclinical study in dogs showed that the oral lipidic NT formulation showed less variability in absorption between the fasted and fed state compared to TU and that very little TU was absorbed in the fasted state, confirming previous results in the literature (26). The results for the NT formulation was confirmed in hypogonadal men where the NT formulation showed similar pharmacokinetics when taken fasted or fed and the ratio of DHT to testosterone was lower for NT than TU.

It is known that native testosterone is absorbed orally but because of the extensive presystemic metabolism in the gastrointestinal tract and rapid first-pass metabolism in the liver, a high dose is required to replace physiological circulating serum testosterone levels (1). This is compounded by the fact testosterone is practically insoluble in water and fatty acid oils (22), so it has been challenging to generate a solution formulation of testosterone with a testosterone concentration sufficient to replace circulating testosterone levels.
We have addressed this by generating a lipidic solution formulation where testosterone is held in solution in the oil phase through the addition of co-solvents: ethanol and benzyl alcohol. The formulation is stable at room temperature for up to 2 years and provides reproducible physiological testosterone levels in hypogonadal men.





post #4




Your only options would be oral esterified TU (Jatenzo, Tlando or Kyzatrex) and even then depending on your insurer you may run into issues.



*The insurance hurdle can easily be overcome as one can skip the hassle and pay out-of-pocket for any of the oral TU (Jatenzo, Tlando and Kyzatrex) formulations
 
I am taking Kizatrex for 3 weeks. So far, so good.

Hello Nelson,

50 year old male here with low T about to start TRT for the first time. I just received my Kyzatrex and will be taking 200mg twice a day for a total of 400mg a day. I see you are trying Kyzatrex as well and seem to like it. Any pros and cons over injections you have noticed thus far?

How much HCG would you suggest using alongside the 400mg a day of Kyzatrex and what would be the dosing interval? Thanks very much for your input!
 
post #2





*mean increases from baseline in hematocrit were observed in both treatment groups at each study visit but remained within the normal range in most men (97% oral TU; 100% topical T).

*Shifts from normal hematocrit values at baseline to above the normal range were observed in 3% of oral TU patients at the final visit, compared with none of the topical T patients






*The formulations with the lowest risk of erythrocytosis are intranasal testosterone (0-2%) and oral testosterone (0.03%).3 A phase 3 clinical trial of testosterone undecanoate (Jatenzo) reported 4.8% patients experienced an increase in hematocrit, although not severe enough to warrant therapy discontinuation.2





      • Risk/rate of erythrocytosis according to formulation:
        • Intramuscular injections – 40%
        • Subcutaneous pellets – 35%
        • Transdermal – 15%
        • Androgel – 3%
        • Intranasal testosterone – 0–2%
        • Oral testosterone – 0.03%





Looking Ahead

The market now boasts a wide range of commercially available options, including novel oral formulations with favorable safety profiles and no liver toxicity concerns. However, it remains crucial to monitor blood pressure in patients prescribed oral TRT.




View attachment 44776




View attachment 44777





Throw this in there too!





Adverse events

Red blood cell mass


Mean Hgb was 14.7g/dL at baseline, 15.1g/dL at Day 90, and 15.2g/dL at Day 180, for a mean increase of 0.5 g/dL, appearing to plateau between 90 and 180 days of treatment. There were 21 (14.7%) study participants with Hgb values greater than the upper limit of the lab normal range (16.9 g/dL) at the final study visit. Three participants (1.9%) had a TEAE of increased Hgb, with maximum values of 18.7, 17.1, and 18.0 g/dL. As noted earlier, Hgb was used as an index of red blood cell mass.




Results of liver enzymes and blood chemistry

There was no clinically significant change in mean values for LFTs throughout the study. There were also no trends over time in the percent of participants LFT values between 1–2×,2–3×, or > 3× the ULN for alanine transaminase (ALT), aspartate trans-aminase (AST),alkaline phosphatase (ALP), or bilirubin. One participant had elevated LFT values prior to the start of dosing and withdrew at Day 120 because of persistent elevation (ALP, ALT, and AST). There were no clinically significant changes in blood urea nitrogen, creatinine, sodium, potassium, or calcium.




Results of lipid profiles

From baseline, total cholesterol decreased 11.1 mg/dL (−5.2%), low-density lipoprotein cholesterol decreased 4.0 mg/dL (−0.8%), high density lipoprotein (HDL) cholesterol decreased 6.9 mg/dL (−14.0%), and triglycerides decreased 18.6 mg/dL (−1.2%). The median decrease from baseline for triglycerides was 6.0 mg/dL (−6.1%)
 
Does anyone have a link to the doctor talking about taking a second dose of TU early afternoon?

 
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