Phlebotomy Study of Testosterone Undecanoate
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|ClinicalTrials.gov Identifier: NCT02670343|
Recruitment Status : Completed
First Posted : February 1, 2016
Results First Posted : March 9, 2018
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism||Drug: Oral Testosterone Undecanoate||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluation of Blood Collection Methodology Following Administration of a Single-Dose of an Oral Testosterone Undecanoate Formulation In Hypogonadal Men|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Oral Testosterone Undecanoate
A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.
Drug: Oral Testosterone Undecanoate
Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.
Other Name: testosterone undecanoate
- % of Mean Difference in T Concentration Compared to Plain Collection Tube [ Time Frame: Sample collection at -0.5, and 0 hours pre-dose and post-dose samples collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12, hours after a single dose of oral TU. ]
The measured outcome presented is the difference as a percent of mean of T results when comparing T Concentrations measured in three different types of NaF containing collection tubes (NaF+EDTA, NaF+Oxalate and NaF) to T measured in blood collected in plain tubes. The % of Mean Difference in T concentration for each tube type was obtained by taking the average at each time point a T concentration was obtained, and calculating the mean difference between the test ((NaF+EDTA, NaF+Oxalate and NaF) tubes and the control (plain) tube.
The concentration of total T will be determined in the serum/plasma samples of all subjects using validated LC/MS/MS methods at the Endocrine and Metabolic Research Lab.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670343
|United States, California|
|Los Angeles Biomedical Research Institute|
|Torrance, California, United States, 90502|
|Principal Investigator:||Christina Wang, M.D.||Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center|