A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Completed · Phase 3

Conditions studied: Hypogonadism

In brief

A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Key facts

Study ID

NCT02722278

Run by

Clarus Therapeutics, Inc.

People needed

222

Starts

2016-03-01

Expected to finish

2016-11-01

Last updated by the study team

2018-02-23

Who can join

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

You may qualify if…

• Man 18 to 65 years of age, inclusive, with hypogonadism as defined by 2 AM total T values of <300 ng/dL drawn on 2 separate days ([approximately 7 days apart]).
• Adequate venous access
• Must be naïve to androgen-replacement therapy or washed out of prior androgen replacement therapies; willing to cease current T treatment or currently not be taking T treatment. Subjects must remain off all forms of T, except for dispensed study drug, throughout the entire study.
• Subjects on replacement therapy for hypopituitarism or multiple endocrine deficiencies must be on stable doses of thyroid hormone and adrenal replacement hormones for at least 14 days before Screen 1.
• Voluntarily given written informed consent to participate in this study.

You may not qualify if…

• 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.
• Received oral TU in a previous Clarus-sponsored investigational study.
• Significant intercurrent disease of any type; in particular, liver, kidney, uncontrolled or poorly controlled heart disease, including hypertension, congestive heart failure or coronary heart disease, or psychiatric-illness, including severe depression.
• Recent (within 2 years) history of stroke, transient ischemic attack, or acute coronary event.
• A mean of the triplicate assessment of systolic blood pressure (sBP) > 150 mm Hg and/or diastolic blood pressure (dBP) > 90 mm Hg at screening.
• Recent (within 2 years) history of angina or stent (coronary or carotid) placement.
• Untreated, severe obstructive sleep apnea.
• Clinically significant abnormal laboratory values (serum transaminases > 2 × ULN, serum bilirubin > 1.5 × ULN and serum creatinine > 1.5 × ULN).
• Hematocrit (HCT) value of < 35% or > 48%.
• Has a history of polycythemia, either idiopathic or associated with testosterone replacement therapy (TRT).
• Glycosylated hemoglobin (A1C) > 8.5%.
• BMI ≥ 38 kg/m2.
• If receiving the following medications:
• Has been on stable doses of lipid-lowering medication for < 3 months;
• Has been on stable doses of oral medication for diabetes for < 2 months; or
• Has been on stable doses of antihypertensive medication for < 3 months.
• Abnormal prostate digital rectal examination (palpable nodules), elevated Prostate Specific Antigen (serum PSA > 4.0 ng/mL), International Prostate Symptom Score (I-PSS) > 19 points at screening, and/or history of, or current or suspected, prostate cancer.
• History of, or current or suspected, breast cancer.
• History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation within the previous 2 years.
• Use of dietary supplements such as saw palmetto or phytoestrogens and any dietary supplements that may increase total T, such as androstenedione or dehydroepiandrosterone within the previous 4 weeks.
• Known malabsorption syndrome and/or current treatment with oral lipase inhibitors and bile acid-binding resins.
• Inability to refrain from smoking during the confinement periods as required by the individual study center.
• History of alcohol abuse or any drug substance within the previous 2 years.
• Poor compliance or unlikely to keep clinic appointments.
• Has received any drug as part of another research study within 30 days of initial dose administration in this study.

Where it is running

• Multiple Sites in the United States — Northbrook, Illinois, United States

Full record on ClinicalTrials.gov

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