Corrigendum to a new oral testosterone undecanoate (TU) therapy comes of age for the treatment of hypogonadal men

Swerdloff RS, Dudley RE. A new oral testosterone undecanoate therapy comes of age for the treatment of hypogonadal men. Therapeutic Advances in Urology 2020 June. DOI: 10.1177/1756287220937232.

In this article, published in issue 12(12) of Therapeutic Advances in Urology, the authors wish to correct the % value listed for Cmax ⩾ 1800–2500 for Day 120 Trial II in Table 3, located on page 7. Correct Table 3 is given below:

Table 3.

Efficacy results for oral TU patients in trials I and II.

Target T ranges (ng/dL)	% N in each range (over 24 hrs) a	95% confidence interval b
Day 90 trial I
Cavg 300–1000	83.6 (N = 122)	76.5, 89.2
Cmax ⩽ 1500	58.9
Cmax ⩾ 1800–2500	13.0
Cmax > 2500	13.7
Day 365 Trial I
Cavg 300–1000	85.0 (N = 108)	N/A
Day 120 Trial II
Cavg 252–907	87.3 (N = 166)	81.3, 92.0
Cmax ⩽ 1500	90.7
Cmax ⩾ 1800–2500	2.0
Cmax > 2500	2.0 c

a

On Final PK day after up to 2 dose adjustment opportunities. Cavg in eugonadal range must be achieved by ⩾75% of oral TU patients to satisfy FDA efficacy standard.

b

Minimum lower bound of 95% confidence interval must be ⩾65% to satisfy FDA standard.

c

N = 3 patients; high Cmax occurred only after AM oral TU dose at single site. Further investigation indicated probable sample contamination during sample handling.