Trial Outcomes & Findings for Phlebotomy Study of Testosterone Undecanoate (NCT NCT02670343)
NCT ID: NCT02670343
Last Updated: 2018-03-09
Results Overview
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.
COMPLETED
PHASE1/PHASE2
8 participants
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.
2018-03-09
Participant Flow
Participant milestones
| Measure |
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.
Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phlebotomy Study of Testosterone Undecanoate
Baseline characteristics by cohort
| Measure |
Oral Testosterone Undecanoate
n=8 Participants
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.
Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 11.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Oral Testosterone Undecanoate
n=8 Participants
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.
Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.
|
|---|---|
|
% of Mean Difference in T Concentration Compared to Plain Collection Tube
NAF+EDTA
|
8.6 Difference as % of Mean of T results
Standard Deviation 18.3
|
|
% of Mean Difference in T Concentration Compared to Plain Collection Tube
NAF+Oxalate
|
16.6 Difference as % of Mean of T results
Standard Deviation 18.5
|
|
% of Mean Difference in T Concentration Compared to Plain Collection Tube
NAF
|
23.2 Difference as % of Mean of T results
Standard Deviation 20.9
|
Adverse Events
Oral Testosterone Undecanoate
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Christina Wang, MDAssociate Director UCLA Clinical and Translational Science Institute
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place