Is Oral Testosterone a Potential Treatment for COVID-19 in Men?

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Lipocine Announces Presentations at the 21st Annual Fall Meeting of the Sexual Medicine Society of North America

Is Oral Testosterone a Potential Treatment for COVID-19 in Men?
-- TLANDO™, Oral Testosterone Replacement Therapy Without Dose Titration Requirement


SALT LAKE CITY, Oct. 14, 2020


SALT LAKE CITY, Oct. 14, 2020,/PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it will present results from studies suggesting that low testosterone levels may play an important role on the clinical outcomes of COVID-19 in men as well as the safety and efficacy of TLANDO™, an oral testosterone replacement therapy without a dose titration requirement, at the 21st Annual Fall Scientific Meeting of the Sexual Medicine Society of North America ("SMSNA"). Lipocine will outline the possible mechanisms and clinical evidence that suggests men with low testosterone have poor COVID-19 outcomes and the rationale of using oral testosterone therapy for men with COVID-19. Results from the previously completed dose validation ("DV") study of a fixed-dose TLANDO in hypogonadal males will also be presented at the meeting. The presentations will take place virtually on November 9, 2020, from 7:00 p.m. – 9:00 p.m. EST during Session 2 (Androgens and Ejaculation/Orgasm Disorders).

"We know that while COVID-19 infection rates are comparable between men and women, men are developing severe symptoms and dying at a significantly higher rate than women. Furthermore, men with comorbidities commonly associated with lower testosterone are at greater risk for severe disease and death," said Dr. Mahesh Patel, Chairman, President, and CEO of Lipocine Inc. "The presentation on COVID-19 highlights key clinical evidence suggesting that low testosterone levels may play an important role in the clinical outcomes of COVID-19 in men. Based on the published data, the use of oral testosterone with the goal of achieving physiological testosterone levels should be evaluated in clinical trials of COVID-19."

Dr. Anthony DelConte, Chief Medical Director of Lipocine further stated, "TLANDO will be the first oral testosterone for treatment hypogonadism without titration requirement. It is expected to be easy to prescribe and use." Dr. DelConte added, "The SMSNA presentation on TLANDO highlights the key safety and efficacy data from multiple clinical studies supporting TLANDO's ability to effectively restore testosterone levels in hypogonadal men without the need for any dose adjustment."
 

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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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