Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men

Completed · Phase 2

Conditions studied: Hypogonadism

In brief

The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.

Key facts

Study ID

NCT00695110

Run by

Clarus Therapeutics, Inc.

People needed

29

Starts

2008-06-01

Expected to finish

2009-08-01

Last updated by the study team

2021-06-25

Who can join

Age: 18 and older, up to 68. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male, ages 18-68
• Serum total T less than or equal to 275 ng/dL

You may not qualify if…

• Significant intercurrent disease of any type, in particular, liver, kidney or heart disease, uncontrolled diabetes mellitus or psychiatric illness.
• Abnormal prostate digital rectal examination, elevated prostate-specific antigen (PSA), American Urological Association (AUA) symptom score of >15, and/or history of prostate cancer.
• Hematocrit of <35 or >50%
• Body mass index (BMI) >36
• Serum transaminases > 2 times upper limit of normal or serum bilirubin > 2.0 mg/dL

Where it is running

• Alabama Clinical Therapeutics — Birmingham, Alabama, United States
• Alabama Internal Medicine — Birmingham, Alabama, United States
• Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center — Los Angeles, California, United States
• dgd Research, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.