Pharmacokinetic Study to Determine Time to Steady-state

Completed · Phase 2

Conditions studied: Male Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism

In brief

The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.

Key facts

Study ID

NCT00911586

Run by

Clarus Therapeutics, Inc.

People needed

15

Starts

2009-07-01

Expected to finish

2010-01-01

Last updated by the study team

2020-12-11

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male, age 18-75
• Morning serum testosterone (T) <300 ng/dL on two occasions
• Naive to androgen-replacement therapy or willing to wash-out from current T therapy

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

• Alabama Clinical Therapeutics — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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