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

For all subjects participating in MRS-TU-2019EXT, whether rolling over from MRS-TU-2019 (after washout) or newly enrolling, the following MRS-TU-2019EXT Inclusion/Exclusion Criteria apply:

Inclusion Criteria

• Completion of MRS-TU-2019 Day 365/ End of Treatment

Exclusion Criteria

• Upper arm circumference > 45 cm.
• Long distance driving or planned driving trip (> 60 mins duration where the subject is doing the driving) during period of wearing ABPM cuff.
• Expected / known forthcoming change to antihypertensive medication(s) during the MRS-TU-2019 EXT extension study.
• Cardiac arrhythmias that, in the opinion of the investigator, interfere with the ability of the ABPM recorder to obtain reliable measurements.
• Use of T implantable pellets since completion of Day 365/EOT visit in MRS-TU- 2019.

For newly enrolling subjects into MRS-TU-2019EXT (naïve to MRS-TU-2019), the applicable Inclusion/Exclusion criteria from the MRS-TU-2019 study, also must be met :

MRS-TU-2019 Key Inclusion Criteria:

• Male aged 18 to 65 years, inclusive, at the time of providing informed consent to participate in the study.
• Hypogonadism defined as having 2 consecutive serum total T levels ≤ 281 ng/dL based on a blood sample, drawn at least 3 days apart, between 7 a.m. and 10 a.m.
• At least 1 clinical feature consistent with male hypogonadism. If a subject is receiving commercial TRT prior to Screening Visit 1, he must have a history of at least 1 clinical feature consistent with male hypogonadism.
• Must be naïve to androgen replacement therapy or washed out adequately of prior androgen replacement therapies; willing to cease current T treatment; or currently not taking any T treatment. Subjects must remain off all forms of T, except for dispensed study drug, throughout the entire study.
• No unstable ongoing concomitant medical conditions. Treated and well-controlled conditions such as type 2 diabetes, hypertension, or dyslipidemia are acceptable with stable medication in place for at least 3 months prior to study entry:
• Hemoglobin A1c 2.5 ng/ml and/or abnormal prostate gland on palpation, e.g., palpable nodes, at Screening Visit 2.
• Received oral, topical, intranasal, or buccal T therapy within the previous 2 weeks, intramuscular T injection of short-acting duration within the previous 4 weeks, intramuscular T injection of long-acting duration within the previous 20 weeks, or T implantable pellets within the previous 6 months.

*For ABPM Extension Study Only: Newly Enrolled Subjects to MRS-TU-2019EXT ABPM Extension Study, patients must not have received prior testosterone replacement therapy within 8 weeks of the start of the study, with the exception of T implantable pellets which are excluded for 6 months.

• Use of any drug that could interfere with measurement or assessment of serum androgen levels, including 5 alpha-reductase inhibitors, anabolic steroids, and drugs with antiandrogenic properties (e.g., spironolactone, cimetidine, flutamide, bicalutamide, and ketoconazole). These drugs must be stopped for at least 1 month prior to study entry (6 months in the case of dutasteride). Patients taking potent, long- acting opiate therapy on a daily basis are not eligible for the study. Conversely, ad hoc use of potent, short-acting opiates for a period of less than 7 days may be permitted after discussion with the Marius Pharmaceuticals medical monitor.
• Use of over-the-counter products, including natural health products (e.g., food supplements and herbal supplements such as saw palmetto or phytoestrogens) that may affect total T levels, within 7 days prior to study entry.
• History of drug or alcohol abuse within the past 2 years that in the opinion of the investigator could interfere with study participation and/or influence study efficacy and safety endpoints assessments.
• Unstable or chronic disease that could interfere with participation in the study or patient safety, including psychiatric disorders.
• Myocard