Testosterone Therapy Tied to Increase in Short-Term VTE Risk
Among men with and without hypogonadism, testosterone therapy linked to elevated VTE risk
Among men with and without hypogonadism, testosterone therapy linked to elevated VTE risk
The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Lipocine regarding the New Drug Application for Tlando (testosterone undecanoate), an oral testosterone product candidate for testosterone replacement therapy in adult males with primary hypogonadism or hypogonadotropic hypogonadism. In the CRL, the Agency noted that the trial establishing the efficacy of…
Selective estrogen receptor modulators (SERMs) may be effective for treating male infertility, according to a recent systematic review and meta-analysis published in Expert Opinion on Pharmacotherapy. SERMs are compounds that exhibit tissue-selective estrogen receptor agonist and antagonist activity. Clomiphene citrate and tamoxifen are two agents commonly used for the off-label management of male infertility. To…
The Food and Drug Administration (FDA) has approved Jatenzo (testosterone undecanoate; Clarus Therapeutics) capsules for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
Prior to starting Xyosted, the patient’s baseline cardiovascular risk should be considered and blood pressure should be adequately controlled.
Xyosted carries a Boxed Warning regarding blood pressure increases that may potentially increase the risk for major adverse cardiovascular events.
The patient was discharged from the hospital with a drug regimen which included aspirin, carvedilol, digoxin, valsartan, and furosemide.
The researchers found that total testosterone use increased among men from 0.52% in 2002 to 3.20% in 2013, but then decreased to 1.67% in 2016.
To evaluate safety and efficacy of this therapy, study authors gathered data on patients treated with the combination from 2014 to 2017.
Clinicians should use a total testosterone level below 300ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone.