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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clarus Therapeutics, Inc.
• Collaborators: Los Angeles Biomedical Research Institute; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Male, ages 18-68

• Serum total T less than or equal to 275 ng/dL

Exclusion Criteria:

• 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