Safety and Efficacy Trial of Testosterone Undecanoate



Status:Completed
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:12/14/2017
Start Date:January 2013
End Date:July 2013

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

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


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
We found this trial at
27
sites
1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
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Medford, OR
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2950 Halcyon Ln # 706
Jacksonville, Florida 32223
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Jacksonville, FL
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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San Antonio, TX
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Aventura, Florida 33180
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Aventura, FL
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1 Presidential Boulevard
Bala-Cynwyd, Pennsylvania 19004
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Bala-Cynwyd, PA
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Birmingham, Alabama 35235
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Birmingham, AL
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Birmingham, Alabama 35235
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Brandon, Florida 33511
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Brandon, FL
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Carrollton, Texas 75010
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Carrollton, TX
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Clearwater, Florida 33756
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Clearwater, FL
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Dallas, Texas 75010
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Garden Grove, California 92844
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Glendale, AZ
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Houston, Texas 77074
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Houston, TX
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Huntsville, Alabama 35801
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Hurst, Texas 76053
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24422 Avenida De La Carlota
Laguna Hill, California 92653
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Los Angeles, California 90048
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Middlebury, Connecticut 06762
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New York, New York 10016
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Phoenix, Arizona 85027
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3815 East Bell Road
Phoenix, Arizona 85032
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Renton, Washington 98057
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Renton, WA
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San Diego, California 92120
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Torrance, CA
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Tucson, AZ
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