Priapism Risk Using AndroGel
Hypogonadism Treatment Update
For men with hypogonadism, the preferred treatment is testosterone replacement therapy (TRT). However, patients are often told that testosterone replacement therapy can cause too frequent or prolonged erections. This potential side effect was studied by researchers from Johns Hopkins University in Baltimore, MD.
The article reporting their results is “Testosterone Replacement with 1% Testosterone Gel and Priapism: No Definite Risk Relationship.” It was published online ahead of print on January 24, 2013, and it will soon appear in The Journal of Sexual Medicine.
The study focused on hypogonadal men (or near hypogonadal) who were being treated with a 1% testosterone gel—AndroGel. Researchers assessed the safety and tolerability of AndroGel by looking at the results from 3 randomized, controlled clinical trials:
- Study 1: Phase 3 trial of AndroGel 1% 5 g, 7.5 g, or 10 g once daily for 6 months. There were 227 men in the study.
- Study 2: Phase 2 trial of AndroGel 1% 7.5 g once daily titrated as needed. This was compared to placebo. The trial was done for 26 weeks in men with type 2 diabetes; there were 180 participants.
- Study 3: This was a Phase 4 trial of AndroGel 1% 5 g once daily vs placebo. It was a 12 week study, and the participants were all men who had been unresponsive to sildenafil 100 mg monotherapy. During the study, the 75 men received concomitant sildenafil 100 mg.
Additionally, 2001 to 2011 post-marketing AndroGel pharmacovigilance reporting data was searched for priapism.
The main outcome the researchers were looking for in all these studies was the incidence of priapism. They were also looking for related symptoms that were reported as reproductive system or urogenital adverse events.
Results of the Study
In all the trials, there were 283 men using AndroGel 1%. The mean exposure ranged from 84 to 149 days.
No adverse events of priapism or related symptoms were reported in any of the trials.
The post-marketing data—which represented 40 million units sold—showed 8 cases of priapism. Six of those cases were judged as possibly related to AndroGel.
Conclusions about AndroGel and Priapism
These 3 clinical trials, as well as the post-marketing data, suggest that there is a minimal risk of AndroGel inducing priapism.