Status:
COMPLETED
Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
Lead Sponsor:
Clarus Therapeutics, Inc.
Collaborating Sponsors:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Conditions:
Hypogonadism
Eligibility:
MALE
18-68 years
Phase:
PHASE2
Brief 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.
Detailed Description
Determination of the steady-state serum T pharmacokinetic profiles for two oral formulations of T-esters \[testosterone undecanoate (TU) and TU combined with testosterone enanthate (TE)\] administered...
Eligibility Criteria
Inclusion
- Male, ages 18-68
- Serum total T less than or equal to 275 ng/dL
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00695110
Start Date
June 1 2008
End Date
August 1 2009
Last Update
June 25 2021
Active Locations (4)
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1
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
2
Alabama Internal Medicine
Birmingham, Alabama, United States, 35235
3
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Los Angeles, California, United States, 90502
4
dgd Research, Inc.
San Antonio, Texas, United States, 78229