Hypogonadism Archives - MPR

Hypogonadism

MPR Weekly Dose Podcast Episode 21

This week on the Pod we cover an insulin pump recall; Pharmacies running out of supplies in light of Covid-19 fears; Investigational Alzheimer disease treatments not meeting trial end points; A new cardiac ultrasound device; and a new oral testosterone replacement therapy.

FDA Again Rejects NDA for Oral Testosterone Product Candidate

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 May Be Effective for Male Infertility

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…

New Oral Tx Approved for Males With Certain Types of Hypogonadism

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.