Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

Completed · Phase 2

Conditions studied: Male Hypogonadism

In brief

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.

Key facts

Study ID

NCT00924612

Run by

Clarus Therapeutics, Inc.

People needed

16

Starts

2009-07-01

Expected to finish

2010-07-01

Last updated by the study team

2020-12-02

Who can join

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

You may qualify if…

• Male
• Age 18-65
• Morning serum testosterone (T) <300 ng/dL on two occasions

You may not qualify if…

• 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%
• BMI >36
• Untreated, obstructive sleep apnea.

Where it is running

• LABiomedical Research Institute at Harbor-UCLA Medical Center — Torrance, California, United States
• Anapharm, Inc. — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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