Jatenzo: An Advancement in Oral TRT

[madman]

An Advancement in Oral Testosterone Replacement Therapy

Join Dr. Jennifer Caudle as she welcomes Dr. Adrian Dobs and Dr. Faysal Yafi to discuss testosterone replacement therapy and an oral softgel option for appropriate hypogonadal men. Topics in this program include safety results from inTUne, the Phase 3, randomized, open-label study of JATENZO...

reachmd.com

Join Dr. Jennifer Caudle as she welcomes Dr. Adrian Dobs and Dr. Faysal Yafi to discuss testosterone replacement therapy and an oral soft gel option for appropriate hypogonadal men. Topics in this program include safety results from inTUne, the Phase 3, randomized, open-label study of JATENZO, the first and only FDA-approved oral soft gel for testosterone replacement therapy. Please see Important Safety Information and Prescribing Information, including BOXED WARNING on increases in blood pressure.

 

[madman]

 

[madman]

 

[madman]

 

[madman]

 

[madman]

 

[madman]

 

[Nelson Vergel]

I wonder what they consider normal testosterone. I bet it is total T over 350 ng/dL

 

[madman]

I wonder what they consider normal testosterone. I bet it is total T over 350 ng/dL

Anything above 300 ng/dL is considered normal.....LOL!

Let alone many endos treating men for low-t are dead set on keeping T levels within the mid-normal range.....go figure.

 

[DadOfSonNOVA]

Geez, we all don’t have endless hours. I wish when ppl post videos, they’d at least summarize what’s said. Reading is such a more efficient way to convey info. Videos just seem lazy to me. 1.5 hours of video. Jeez. To say what? Oral good, oral bad??? How can that take more than 1.5 hours??????

 

[madman]

Geez, we all don’t have endless hours. I wish when ppl post videos, they’d at least summarize what’s said. Reading is such a more efficient way to convey info. Videos just seem lazy to me. 1.5 hours of video. Jeez. To say what? Oral good, oral bad??? How can that take more than 1.5 hours??????

The video is roughly 13 min (13:32)

Jatenzo, an Oral Testosterone Replacement Therapy

Clarus Therapeutics Announces Commercial Launch and Availability of JATENZO® (testosterone undecanoate) capsules, CIII for the Treatment of Hypogonadism Clarus Therapeutics Announces Commercial Launch and Availability of JATENZO® (testosterone undecanoate) capsules, CIII for the Treatment of...

www.excelmale.com

This may suit your fancy.....hope you have the time!

Jatenzo presentation: https://www.fda.gov/media/110642/download

 

[Nelson Vergel]

Dietary Fat Modulates the Testosterone Pharmacokinetics of a New Self-Emulsifying Formulation of Oral Testosterone Undecanoate in Hypogonadal Men​

This study investigates the effect of dietary fat on the testosterone (T) pharmacokinetics in hypogonadal men following administration of a self-emulsifying capsule formulation of oral T undecanoate (TU). In an open-label, 2-center, 5-way crossover study, a single oral dose of TU containing 300-mg equivalents of T (maximum anticipated human dose per administration) was administered to 16 hypogonadal men with a washout period of at least 5 days between doses. All participants were randomized to receive the TU capsules fasting or 30 minutes after an approximately 800-calorie meal containing 10%, 20%, 30%, or 50% fat. Serial blood samples were collected from 2 hours predose to 25 hours postdose to determine serum T and dihydrotestosterone (DHT) by liquid chromatography tandem mass spectrometry. Administering TU with a meal increased serum T concentrations, with the magnitude of the increase being directly dependent on the amount of fat in the meal. Average and peak serum T concentrations and area under the curve increased as the fat content of the meal was increased. Neither the high-fat meal (50% fat) nor the lower-fat meal (20% fat) showed a significant food effect relative to the normal-fat (Western diet) meal (30% fat). However, administering TU while fasting resulted in 50% or less of the cumulative exposure obtained when administered with 20%- to 50%-fat meals (albeit still substantial). A very-low-fat meal (10% fat) showed a significant food effect relative to the normal meal, but still exceeded the fasting condition by approximately 50%. Serum DHT concentrations showed corresponding increases to the serum T. As expected with the maximum anticipated clinical dose of TU (300 mg T), oral administration of this new formulation with food containing 20% to 50% dietary fat produced T levels at or above the upper range of adult men, and T levels trended higher as dietary fat content increased. Only with a very-low-fat diet (10%) or in a fasted state did a clinically significant food effect occur, but even then sufficient TU was absorbed with the self-emulsifying TU formulation to produce average serum T concentration predicted to be in the normal reference range (10 to 35 nmol/L).

Dietary Fat Modulates the Testosterone Pharmacokinetics of a New Self-Emulsifying Formulation of Oral Testosterone Undecanoate in Hypogonadal Men

This study investigates the effect of dietary fat on the testosterone (T) pharmacokinetics in hypogonadal men following administration of a self-emulsifying capsule formulation of oral T undecanoate (TU). In an open-label, 2-center, 5-way crossover study, ...

www.ncbi.nlm.nih.gov

 

[Nelson Vergel]

ClinicalTrials.gov

clinicaltrials.gov

 

[Nelson Vergel]

More Jatenzo posts on ExcelMale.com

 

[Nelson Vergel]

 

[Nelson Vergel]

My Experience On Jatenzo (Oral TRT) Log

I wanted to start a thread detailing my personal experience with Jatenzo (oral TRT) which is remarkable in how quickly it has shown results when compared with injections. The first week on Jatenzo was very pleasant unlike my experience after dosing changes on injections, all with minimal swings...

www.excelmale.com

 

[Nelson Vergel]

Oral Testosterone, Testosterone and COVID, and TRT Myths

Mohit Khera, MD, MBA, MPH, discusses testosterone therapy options for COVID-19, prostate cancer, and more.

www.excelmale.com

 

[Nelson Vergel]

Tlando: Another Oral Testosterone Undecanoate OK'd for Hypogonadism

FDA approval of Tlando follows in the footsteps of Jatenzo The recommended dosage is 225 mg orally twice daily with food. It does not require dose titration. "We believe Tlando's oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment...

www.excelmale.com