man having stroke from fortesta

Fortesta is a testosterone supplement made and sold by Endo Pharmaceuticals. The FDA approved Fortesta for treating hypogonadism in December 2010.


General Information

Fortesta is a gel delivered by a metered pump. The patient applies the gel to his thighs every morning. A typical starting dose is 40 milligrams a day (4 pumps); this rate can be adjusted up and down by 10 milligram increments. The gel is odorless, clear and colorless; it is used to treat men who cannot make enough endogenous testosterone due to acquired or congenital conditions.

The maximum dose is 70 milligrams a day of testosterone. At both 14 days out from treatment and 30 days out from treatment, the manufacturer recommends that the patient submit to blood tests to measure testosterone concentrations. His doctor can adjust dosage based on those data.

Study on Fortesta

The FDA approved Fortesta after a short (90 day) study of 149 men who suffered from hypogonadism. By day 90, more than three quarters of the men who remained in the study had normal steady state serum testosterone levels. The study also found no clinically significant changes testosterone to DHT ratio, sex hormone binding globulin (SHBG) levels, or E2 levels.

Side effects in the study included application site reactions, weird dreams among participants and an increase in prostatic specific androgen. The study was an “open label, non-comparative” trial — not the gold standard for research. (Ideal would be a double blind, placebo controlled randomized trial.)

What is the difference? Why shouldn’t an open level, non-comparative trial be enough?b52ede69bac34821869bde3adbdf44ba-fortesta_158963

First of all, consider the sample size: the trial followed just 149 men for only 90 days. That is not enough time to ascertain whether any of the men might elevate their long term risk for conditions like myocardial infarction, stroke, blood clotting, liver and renal disease.

Ideally, a study should be designed to follow a diverse group of hypogonadal men for years and track not just short term changes in markers like testosterone and SHBG but also other critical measures, such as serum lipids and biochemical indicators of blood clotting ability.

It would also be nice to compare men who get the intervention with a group that gets a placebo, since the act of taking any drug (even a placebo) can lead to physiological changes.

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