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

Completed · Phase 3

Conditions studied: Hypogonadism, Male

In brief

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).

Key facts

Study ID

NCT04467697

Run by

Marius Pharmaceuticals

People needed

155

Starts

2018-09-18

Expected to finish

2020-05-01

Last updated by the study team

2024-06-28

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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 < 8.0%
• BP < 150/90 mm Hg
• *for MRS-TU-2019EXT ABPM Extension Study, the in-clinic, average BP must be < 140/90 for inclusion into the MRS-TU-2019EXT study.
• Low-density lipoprotein cholesterol < 190 mg/dL.
• Subjects with an endocrine disorder requiring treatment other than hypogonadism must be on a stable dose of replacement medication for at least 3 months prior to study entry.
• Adequate venous access to allow collection of a number of blood samples via a venous cannula.
• Written informed consent to participate in the study and ability to comply with all study requirements.
• MRS-TU-2019 Key Exclusion Criteria:
• Serum PSA > 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.

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Coastal Clinic Research Inc — Mobile, Alabama, United States
• South Florida Medical Research — Aventura, Florida, United States
• PAB Clinical Research — Brandon, Florida, United States
• Jacksonville Impotence Treatment Center — Jacksonville, Florida, United States
• My Community Research Center — Miami, Florida, United States
• Oviedo Medical Research, LLC — Oviedo, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• Centex Studies, Inc. — Lake Charles, Louisiana, United States
• Quality Clinical Research, Inc. — Omaha, Nebraska, United States
• Palm Research Center, Inc. — Las Vegas, Nevada, United States
• Accumed Research Associates — Garden City, New York, United States
• Manhattan Medical Research Practice, PLLC — New York, New York, United States
• Rapha Institute for Clinical Research — Fayetteville, North Carolina, United States
• Urologic Consultant of SE Pennyslvania — Bala-Cynwyd, Pennsylvania, United States
• Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
• University Diabetes Endocrine Consultants — Chattanooga, Tennessee, United States
• Centex Studies, Inc. — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.