Matching articles for "Natesto"
Two New Oral Testosterone Products for Hypogonadism
The Medical Letter on Drugs and Therapeutics • October 31, 2022; (Issue 1662)
The FDA has approved two new oral formulations
of testosterone undecanoate — Kyzatrex (Marius)
and Tlando (Antares) — for treatment of males
with a deficiency of endogenous testosterone
due to...
The FDA has approved two new oral formulations
of testosterone undecanoate — Kyzatrex (Marius)
and Tlando (Antares) — for treatment of males
with a deficiency of endogenous testosterone
due to conditions such as Klinefelter syndrome,
orchiectomy, toxic damage from chemotherapy or
alcohol, or pituitary-hypothalamic injury caused
by tumors, trauma, or radiation. Jatenzo, another
oral testosterone undecanoate formulation, was
approved for the same indication in 2019. No
testosterone products are approved for treatment of
low testosterone levels due solely to aging.
Safety of Testosterone Replacement Therapy
The Medical Letter on Drugs and Therapeutics • March 14, 2016; (Issue 1490)
Three coordinated double-blind, placebo-controlled
clinical trials have evaluated the efficacy of one year of
testosterone replacement therapy in improving sexual
function, physical function, and vitality in...
Three coordinated double-blind, placebo-controlled
clinical trials have evaluated the efficacy of one year of
testosterone replacement therapy in improving sexual
function, physical function, and vitality in a total of
790 men ≥65 years old with moderately low serum
testosterone concentrations and symptoms suggesting
hypoandrogenism. Sexual function improved
modestly, and there appeared to be marginal benefits
in some areas of physical function and vitality as well.
The trials were not designed to evaluate the safety of
testosterone replacement therapy.
Testosterone Nasal Gel (Natesto) for Hypogonadism
The Medical Letter on Drugs and Therapeutics • May 11, 2015; (Issue 1468)
The FDA has approved an intranasal gel formulation of
testosterone (Natesto – Trimel/Endo) for replacement
therapy in men with hypogonadism. Packaged in a
metered-dose pump, Natesto is the first...
The FDA has approved an intranasal gel formulation of
testosterone (Natesto – Trimel/Endo) for replacement
therapy in men with hypogonadism. Packaged in a
metered-dose pump, Natesto is the first intranasal
testosterone to become available in the US. Like other
testosterone products, it is classified as a schedule
III controlled substance. The FDA recently cautioned
against using testosterone to treat low testosterone
levels solely due to aging because the benefits and
safety of such use have not been established, and there
is a possible increased risk of myocardial infarction (MI)
and stroke.