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 intervalb |
|---|---|---|
| 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 | 2.0c | |
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.
Minimum lower bound of 95% confidence interval must be ⩾65% to satisfy FDA standard.
N = 3 patients; high Cmax occurred only after AM oral TU dose at single site. Further investigation indicated probable sample contamination during sample handling.