STRIANT had a low incidence of adverse events in the US pivotal trial
| Adverse Event |
Total % (N=98) |
| Gum or mouth irritation |
9.2 |
 |
| Bitter taste |
4.1 |
|
| Gum pain |
3.1 |
|
| Gum tenderness |
3.1 |
|
| Headache |
3.1 |
|
| Gum edema |
2.0 |
|
| Taste perversion |
2.0 |
|
*Based on results from a 12-week, multicenter, open-label, single-arm study.
STRIANT is safe to the oral cavity
In the US pivotal trial, the majority of the gum-related adverse events were transient and resolved within 1 to 14 days. The incidence of most gum abnormalities was greater at baseline (pretreatment) than at 4, 8, and 12 weeks on STRIANT.
Four patients (4.1%) discontinued treatment with STRIANT due to gum or mouth-related adverse events including 2 with severe gum irritation, 1 with mouth irritation, and 1 with “bad taste in mouth.”
With STRIANT, there is no increased metabolism of testosterone to DHT as compared with young, heathy eugonadal men.
In the US pivotal trial involving 98 patients, the most frequent adverse events that occurred with an incidence of 1% or greater which were possibly, probably, or definitely related to the use of STRIANT® were: gum or mouth irritation (9.2%), bitter taste (4.1%), gum pain (3.1%), gum tenderness (3.1%), headache (3.1%), gum edema (2.0%), and taste perversion (2.0%). A total of 16 patients reported 19 gum-related adverse events. Of these, 10 patients (10.2%) reported 12 events of mild intensity, 4 patients (4.1%) reported 5 events of moderate intensity, and 2 patients (2.0%) reported 2 events of severe intensity. Four patients (4.1%) discontinued treatment with STRIANT due to gum or mouth-related adverse events including 2 with severe gum irritation, 1 with mouth irritation, and 1 with “bad taste in mouth.” The majority of the gum-related adverse events were transient and resolved within 1 to 14 days. Patients should be advised to regularly inspect the gum region where they apply STRIANT and report any abnormality to their health care professional.
STRIANT is not indicated for women and must not be used in women. Testosterone supplements may cause fetal harm. STRIANT should not be used in patients with known hypersensitivity to any of its ingredients, including testosterone USP that is chemically synthesized from soy.
Androgens are contraindicated in men with carcinoma of the breast or known carcinoma of the prostate. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. Gynecomastia frequently develops and occasionally persists in patients being treated with androgens for hypogonadism. The treatment of hypogonadal men with testosterone esters may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and therefore, insulin requirements.
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