NCT03198728

Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men

A 12-Month, Randomized, Active-controlled, Open-label Study of the Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (RE-TUne)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Marius Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

MRS-TU-2019 was a 12-month study designed to determine the efficacy of oral SOV2012-F1 as measured by the percentage of male hypogonadal subjects with average total testosterone (T Cavg) in plasma within the normal range after 90 days of treatment. This study included an AndroGel™ arm as a safety comparator; after the 90-day efficacy period, dosing continued for 9 additional months in both arms to gather safety data. This study also examined the percentage of SOV2012-F1-treated subjects with maximum total testosterone (Cmax) in plasma values after 90 days of treatment: a. ≤1.5 X upper limit of normal (ULN); b. 1.8 X ULN to 2.5 X ULN' and c. \>2.5 X ULN. The study also included an adrenal cortical function substudy conducted in 30 SOV2012-F1 subjects and 15 AndroGel subjects. Four patient-reported outcome measures were also used during the study: IPSS, PDQ, SF-36 and IIEF.

Conditions

• Hypogonadism, Male

Interventions

Type	Name	Description
DRUG	SOV2012-F1	oral preparation of testosterone undecanoate (TU)
DRUG	AndroGel	topical testosterone gel 1.62%

Timeline

• Start date: 2017-07-05
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2017-06-26
• Last updated: 2023-06-28
• Results posted: 2023-06-28

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study