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Clinical Trial Summary

The purpose of this six-month treatment extension study is - to assess feasibility of a lower starting dose of SOV2012-F1 (daily dose of 400 mg [200 mg with breakfast meal and 200mg with dinner meal]) to titrate individual doses in order to further enhance drug administration. - To examine the blood pressure (BP) effects of Marius's oral testosterone undecanoate formulation, SOV2012-F1, using 24-hour ambulatory blood pressure monitoring (ABPM).


Clinical Trial Description

This is the six-month treatment extension of Study MRS-TU-2019, which like Study MRS-TU-2019 (NCT03198728), is an open-label study. The MRS-TU-2019 ABPM Extension Study (MRS-TU-2019EXT; NCT04467697), will extend the participation for up to 170 MRS-TU-2019 subjects who chose to enroll into the MRS-TU-2019EXT, for a target of 135 evaluable subjects reaching the 4-month ABPM assessment ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04467697
Study type Interventional
Source Marius Pharmaceuticals
Contact
Status Completed
Phase Phase 3
Start date September 18, 2018
Completion date May 1, 2020

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