JATENZO is the first FDA-approved oral softgel for testosterone replacement therapy in adult males who have deficient testosterone due to certain medical conditions NORTHBROOK, Ill., June 09, 2022 (GLOBE NEWSWIRE) -- Clarus Therapeutics Holdings, Inc. (“Clarus”) (Nasdaq:CRXT), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, today announced that new data for JATENZO (testosterone undecanoate) will be presented in the form of an abstract at ENDO 2022, the Endocrine Society’s annual meeting, taking place at the Georgia World Congress Center in Atlanta June 11-14, 2022. Details on the abstract presentation for JATENZO are below. Abstract Title: Comparison Between Single Time Point Testing and 24-Hour Average Concentration of Total Testosterone in Hypogonadal Men Treated with an Oral Testosterone Undecanoate Softgel (JATENZO®) Date/time: Monday, June 13, 2022, 12:30 p.m. – 2:30 p.m. ET
Session/location: PMON267, Hall A1
Male hypogonadism is a condition that results when the testes do not produce enough testosterone. Symptoms associated with male hypogonadism can include depression, decreased sex drive, decreased muscle mass, and decreased bone density, among others. An estimated 20 million men in the United States have hypogonadism, with approximately six million patients diagnosed. Treatments for male hypogonadism may include testosterone replacement therapy. About Clarus Therapeutics Holdings, Inc.
Clarus Therapeutics Holdings, Inc. is a pharmaceutical company with expertise in developing androgen and metabolic therapies for men and women – including potential therapies for orphan indications. Clarus’ first commercial product is JATENZO® (testosterone undecanoate). For more information, visit www.clarustherapeutics.com and www.jatenzo.com. Follow us on Twitter (@Clarus_Thera) and LinkedIn (Clarus Therapeutics). JATENZO® is a registered trademark of Clarus Therapeutics Holdings, Inc. kstancell@clarustherapeutics.com
JATENZO® (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Safety and efficacy of JATENZO in males less than 18 years old have not been established. WARNING: INCREASES IN BLOOD PRESSURE
Before initiating JATENZO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled. Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies. Check hematocrit prior to initiation and every 3 months while a patient is on JATENZO and if hematocrit becomes elevated, stop JATENZO until hematocrit decreases to an acceptable level. If hematocrit increases after JATENZO is restarted, stop permanently. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Large doses of androgens can suppress spermatogenesis by feedback inhibition of pituitary FSH. Inform patients of this risk before prescribing JATENZO. Prolonged use of high doses of methyltestosterone has been associated with serious hepatic adverse events. JATENZO is not known to cause these adverse events; however, patients should be instructed to report any signs of hepatic dysfunction and JATENZO should be discontinued while the cause is evaluated. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. Sleep apnea may occur in some patients, especially those with risk factors such as obesity or chronic lung disease. Changes in the serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically, particularly after starting testosterone therapy. Androgens, including JATENZO, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. These are not all of the risks associated with JATENZO. For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. You can also obtain information regarding JATENZO at www.jatenzo.com.