Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men

Completed · Phase 3

Conditions studied: Hypogonadism, Male

In brief

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.

Key facts

Study ID: NCT03198728
Run by: Marius Pharmaceuticals
People needed: 314
Starts: 2017-07-05
Expected to finish: 2020-05-01
Last updated by the study team: 2023-06-28

Who can join

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

You may qualify if…

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
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.

You may not qualify if…

Serum PSA > 2.5 ng/ml and/or abnormal prostate gland on palpation, eg, 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.
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 (eg, 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 (eg, 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.
Myocardial infarction, coronary artery surgery, heart failure, stroke, unstable angina, or other unstable cardiovascular disease within the past 6 months.
Abnormal ECG considered clinically significant by investigator at Screening.
Diagnosis of any cancer within the previous 5 years other than basal or squamous cell skin cancer with clear margins.
Any surgical or medical condition that might alter administration of the study drug or comparator, including history of gastric surgery, cholecystectomy, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption of TU.
Duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to screening.
Chronic skin conditions on the chest or upper arms that would prevent administration of AndroGel in a manner designed to ensure reliable and consistent absorption thereof.
Human immunodeficiency virus (HIV) infection.
Chronic hepatitis B virus and/or hepatitis C virus (HCV) infection (as determined by positive testing for hepatitis B virus surface antigen or HCV antibody with confirmatory testing, ie, detectable serum HCV ribonucleic acid [RNA]).
Clinically significant abnormal laboratory values at screening including but not limited to:
Elevated liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT] > 2x upper limit of normal)
Estimated glomerular filtration rate < 60 ml/min/1.73m2 as calculated by the Modification of Diet in Renal Disease formula
Hemoglobin < 11.0 g/dL or > 16.0 g/dL. For a subject previously on testosterone replacement therapy with less than 30 days washout prior to screening Visit 2, hemoglobin < 11.0 g/dL or > 17.0 g/dL.
Severe and untreated obstructive sleep apnea syndrome.
Severe lower urinary tract symptoms (American Urological Association/ IPSS ≥ 19).
History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study entry.
Past, current, or suspected prostate or breast cancer.
History of long QT syndrome or unexplained sudden death in a first-degree relative (parent, sibling, or child).
Concurrent treatment with medications that may impact the absorption, distribution, metabolism, or excretion of TU or place the subject at risk for treatment with T.
Subject has a partner who is currently pregnant or planning pregnancy during the course of the study.

Where it is running

Central Research Associates, Inc. — Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
Coastal Clinical Research, Inc. — Mobile, Alabama, United States
Quality of Life Medical and Research Centers, LLC — Tucson, Arizona, United States
San Diego Sexual Medicine — San Diego, California, United States
South Florida Medical Research — Aventura, Florida, United States
PAB Clinical Research — Brandon, Florida, United States
Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
Jacksonville Impotence Treatment Center — Jacksonville, Florida, United States
Health Awareness, Inc. — Jupiter, Florida, United States
Meridien Research — Lakeland, 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
Primary Care Research Group — Atlanta, Georgia, United States
Northwest Clinical Trials — Boise, Idaho, United States
Advanced Clinical Research — Meridian, Idaho, United States
Central Kentucky Research Associates — Lexington, Kentucky, United States
Centex Studies, Inc. — Lake Charles, Louisiana, United States
Men's Health Boston — Chestnut Hill, Massachusetts, 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

Full record on ClinicalTrials.gov

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