The purpose of the study is to determine the effect of food with various amounts of fat on
the absorption of an oral testosterone undecanoate formulation.
Drug: Oral testosterone undecanoate (containing 300 mg of T)
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Full eligibility criteria for NCT00924612
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
Morning serum testosterone (T) <300 ng/dL on two occasions
Significant intercurrent disease
Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history of prostate cancer.
Serum transaminases >2 times upper limit of normal
Serum bilirubin >2.0 mg/dL
Hematocrit <35% or >50%
Untreated, obstructive sleep apnea.
All locations for NCT00924612
United States (1)
LABiomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Quebec City, Quebec, Canada, G1P 0A2
View full eligibility
Tris trial is registered with FDA with number: NCT00924612. The sponsor of the trial is Clarus Therapeutics, Inc. and it is looking for 16 volunteers for the current phase.
Official trial title: Phase II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men
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