Safety and Efficacy Trial of Testosterone Undecanoate

Study Overview
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Brief Summary
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The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.

Official Title
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Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men

Conditions
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Male Hypogonadism

Intervention / Treatment
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* Drug: Oral testosterone undecanoate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Serum testosterone of less than or equal to 300 ng/dL (the mean of two samples collected 1 hour apart in the morning between 6:00 and 10:00 AM) Exclusion Criteria: Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease including hypertension, CHF or CAD, or psychiatric illness including depression. Recent history of stroke, including transient ischemic attack (TIA) or acute coronary event Untreated, severe obstructive sleep apnea Hematocrit <35% or >48% Serum transaminases >2 times upper limit of normal, serum bilirubin >2.0 mg/dL, and serum creatinine >2.0 mg/dL BMI > or equal to 38 Stable doses of lipid-lowering medication for less than three months Stable doses of oral medication for diabetes for less than two months Abnormal prostate digital rectal examination [palpable nodule(s)], elevated PSA (serum PSA >3.9 ng/mL), IPSS score > or equal to 19 points, and /or history of prostate cancer. History of breast cancer Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or DHEA with the previous 4 weeks Know malabsorption syndrome and/or current treatment iwht oral lipase inhibitors Known history of abuse of alcohol or any drug substance with the previous 2 years Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or long-acting opioid analgesics Receipt of any drug as part of a research study within 30 days of initial dose administration in this study Blood donation within the 12 week period before initial dose administration in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral testosterone undecanoate<br> | Drug: Oral testosterone undecanoate<br>* Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL | The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114. | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population | The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114. | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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testosterone, male hypogonadism, low testosterone