Initial Clinical Experience With Testosterone Undecanoate Therapy (AVEED) in Men With Testosterone Deficiency in the United States.

OBJECTIVE: To report our initial experiences with testosterone undecanoate (TU 750) mg (AVEED) in men with testosterone deficiency.

METHODS: All patients receiving TU 750 mg at our center between July 1, 2014, and August 1, 2016, were identified. Clinical response was assessed through structured interviews and laboratory evaluations. Adverse events were documented, including increase in prostate specific antigen (PSA), increase in hematocrit (Hct), and the development of postinjection cough.

RESULTS: More than 2 injections were received by 147 men, with mean age 63.2 years. Mean baseline total testosterone (T) and free T were 305 ng/dL and 0.69 ng/dL, respectively. Nadir mean results during treatment were higher for total and free T, at 413.2 ng/dL and 0.81 ng/dL, respectively (P < .001 for each). Symptomatic improvement was reported by 97 of 147 patients (66.0%). Thirty patients (20.4%) discontinued therapy. Return of symptoms before the next injection was noted by 34%, managed by reduced interval between injections and/or supplemental injections of T cypionate. Three patients (2%) experienced transient cough immediately after TU injection, none requiring intervention. Mean Hct rose from 45.6% to 47.2%. Mean PSA rose from 1.7 ng/mL to 2.0 ng/mL. There were no strokes, myocardial infarctions, or deaths, and no new cases of prostate cancer.

CONCLUSION: This initial clinical experience with TU 750 mg provides evidence for good patient satisfaction and persistence with treatment, together with a favorable safety profile. Optimal dosing may be less than 10 weeks for some individuals.