Pharmacokinetic Study of Testosterone Enanthate
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 1/13/2018 |
| Start Date: | September 2013 |
| End Date: | January 2014 |
3 Arm Open-label Randomized Multidose Study of Pharmacokinetics, Safety & Tolerability of Testosterone Enanthate Administered Subcutaneously Via an Auto-injector Device or Intramuscular Testosterone Enanthate in Hypogonadal Adult Males
Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.
Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area
Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the
treatments and reference arm.
Safety comparisons were based upon the occurrence, severity and rate of treatment emergent
adverse events.
Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the
treatments and reference arm.
Safety comparisons were based upon the occurrence, severity and rate of treatment emergent
adverse events.
Inclusion Criteria:
- Adult males aged 18 to 75 with a documented diagnosis of hypogonadism
Exclusion Criteria:
- Normal testosterone levels
- Subjects with any clinically significant medical condition which, in the opinion of
the Investigator, would make the subject an unsuitable candidate for enrollment in the
study
We found this trial at
1
site
Click here to add this to my saved trials
