Company to seek approval of oral testosterone undecanoate in the United States

Nelson Vergel

Founder, ExcelMale.com
This company is seeking approval of a product already available in Canada as an oral agent to increase testosterone (testosterone undecanoate, the same active agent that Aveed or Nebido contains). This product needs to be taken more than once a day.


Clarus Therapeutics, Inc. recently presented phase III clinical data from two studies that it says support the safety and efficacy of oral testosterone undecanoate (REXTORO) for testosterone replacement therapy in men with hypogonadism. Each trial differed in design, dose-titration algorithm, and duration. Each demonstrated T replacement, and with the revised dose-titration algorithm, the maximum serum T concentration was comparable to other T replacement therapies. The agent met the efficacy endpoint in both studies, said Clarus Therapeutics CEO Robert E. Dudley, PhD, in a press release. The studies were presented at the International Congress of Endocrinology and the Endocrine Society’s Annual Meeting and Expo in Chicago.- See more at: http://urologytimes.modernmedicine....-endpoint-phase-iii-stud#sthash.oztUUa4e.dpuf
 

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TRT Hormone Predictor

Predict estradiol, DHT, and free testosterone levels based on total testosterone

⚠️ Medical Disclaimer

This tool provides predictions based on statistical models and should NOT replace professional medical advice. Always consult with your healthcare provider before making any changes to your TRT protocol.

ℹ️ Input Parameters

Normal range: 300-1000 ng/dL

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Understanding Your Hormones

Estradiol (E2)

A form of estrogen produced from testosterone. Important for bone health, mood, and libido. Too high can cause side effects; too low can affect well-being.

DHT

Dihydrotestosterone is a potent androgen derived from testosterone. Affects hair growth, prostate health, and masculinization effects.

Free Testosterone

The biologically active form of testosterone not bound to proteins. Directly available for cellular uptake and biological effects.

Scientific Reference

Lakshman KM, Kaplan B, Travison TG, Basaria S, Knapp PE, Singh AB, LaValley MP, Mazer NA, Bhasin S. The effects of injected testosterone dose and age on the conversion of testosterone to estradiol and dihydrotestosterone in young and older men. J Clin Endocrinol Metab. 2010 Aug;95(8):3955-64.

DOI: 10.1210/jc.2010-0102 | PMID: 20534765 | PMCID: PMC2913038

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