NCT04467697

Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men

A 6 Month, Open Label, Ambulatory Blood Pressure Monitoring (ABPM) Extension Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Marius Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this six-month treatment 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 to further enhance efficacy and safety. * To examine the blood pressure (BP) effects of Marius's oral testosterone undecanoate formulation, SOV2012-F1, using 24-hour ambulatory blood pressure monitoring (ABPM).

Detailed 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 and to new subjects, for a target of 135 evaluable subjects reaching the 4-month ABPM assessment. All subjects were washed out from previous testosterone therapy if they were not naïve. The study used ABPM monitoring to assess baseline and change from baseline after 120 and 180 days of treatment. The percentage of participants within the normal range for testosterone was assessed after two titration cycles and a total of 90 days of treatment.

Conditions

• Hypogonadism, Male

Interventions

Type	Name	Description
DRUG	SOV2012-F1	Oral preparation of testosterone undecanoate (TU). Strengths of 100 mg TU, 150 mg TU and 200 mg TU

Timeline

• Start date: 2018-09-18
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2020-07-13
• Last updated: 2024-06-28
• Results posted: 2024-06-28

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study