Status:
COMPLETED
Pharmacokinetic Study to Determine Time to Steady-state
Lead Sponsor:
Clarus Therapeutics, Inc.
Conditions:
Male Hypogonadism
Primary Hypogonadism
Eligibility:
MALE
18-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
Serum testosterone levels will be obtained in hypogonadal (serum testosterone \<300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00911586
Start Date
July 1 2009
End Date
January 1 2010
Last Update
December 11 2020
Active Locations (1)
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1
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235