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The intricate hormonal interplay essential for male reproductive health begins with the release of gonadotropin-releasing hormone (GnRH) by the hypothalamus. This hormone prompts the pituitary gland to secrete follicle-stimulating hormone (FSH) and luteinizing hormone (LH). LH targets the Leydig cells in the testes, stimulating them to produce and release testosterone. In concert with testosterone, FSH acts on the Sertoli cells within the seminiferous tubules to facilitate the release of...
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Men's health issues are increasingly recognized as significant, with several conditions posing common threats. Among these, testicular cancer is especially prevalent in younger men, particularly those aged 20 to 35 years. The disease often manifests as a painless mass in the testicles, sometimes accompanied by a sensation of heaviness or a dull ache.
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Cardiovascular Safety of Testosterone-Replacement Therapy.

A Michael Lincoff1, Shalender Bhasin1, Panagiotis Flevaris1

  • 1From the Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland (A.M.L., L.M.M., Q.W., K.W., D.D., V.K., S.E.N.); the Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School (S. Bhasin, S. Basaria, K.M.P.), Veterans Affairs Boston Healthcare System and Massachusetts Veterans Epidemiology, Research, and Information Center, Boston University School of Medicine (W.E.B.), and Marcus Institute for Aging Research, Beth Israel Deaconess Medical Center, Harvard Medical School (T.G.T.) - all in Boston; AbbVie, North Chicago, IL (P.F., N.K., M.G.M., M.C.S., A.C., E.D., X.L., T.Y., B.H.); Baylor College of Medicine, Houston (G.R.C., M.K.), and CHRISTUS Santa Rosa Health System and the University of Texas Health Science Center, San Antonio (I.M.T.) - all in Texas; and Duke Clinical Research Institute, Durham, NC (C.B.G.).

The New England Journal of Medicine
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Testosterone replacement therapy is safe for men with hypogonadism and cardiovascular disease. This study found no increased risk of major adverse cardiac events in men receiving testosterone compared to placebo.

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Area of Science:

  • Endocrinology
  • Cardiovascular Medicine
  • Clinical Trials

Background:

  • Cardiovascular safety of testosterone-replacement therapy (TRT) in hypogonadal men is not well-established.
  • Hypogonadism affects middle-aged and older men, often with pre-existing cardiovascular conditions.

Purpose of the Study:

  • To determine the cardiovascular safety of TRT in men aged 45-80 with hypogonadism and cardiovascular disease or risk.
  • To assess if TRT is noninferior to placebo in preventing major adverse cardiac events.

Main Methods:

  • Multicenter, randomized, double-blind, placebo-controlled, noninferiority trial (TRAVERSE).
  • 5246 men with hypogonadism and cardiovascular disease/risk received daily transdermal testosterone gel or placebo.
  • Primary endpoint: composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

Main Results:

  • Testosterone therapy was noninferior to placebo (HR 0.96; 95% CI 0.78-1.17).
  • No significant difference in primary composite cardiovascular events between groups (7.0% vs 7.3%).
  • Higher incidence of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group.

Conclusions:

  • Testosterone-replacement therapy is noninferior to placebo for major adverse cardiac events in hypogonadal men with cardiovascular disease.
  • While primary safety endpoints were met, increased risks of other adverse events warrant consideration.