Pharmacokinetic Study to Determine Time to Steady-state

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

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

Details

• Lead Sponsor: Clarus Therapeutics, Inc.
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.