Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men

Summary

This will be a randomized, multicenter, open-label, active-controlled, efficacy, and safety study in adult hypogonadal men. The study duration is 12 months (365 days), including a 90-day, open-label efficacy period and a 9-month (275-day) safety evaluation period.

Timeline

Start

2017-07-05

Primary completion

2020-05-01

Completion

2020-05-01

Publications

• Bernstein JS, Dhingra OP. A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product. Ther Adv Urol. 2024 Apr 10;16:17562872241241864. doi: 10.1177/17562872241241864. eCollection 2024 Jan-Dec.

Drugs

Indications