Phase 2
Completed N=39
Pharmacokinetic Study of Testosterone Enanthate
Source: ClinicalTrials.gov NCT01887418 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks — 150445.2; 70955.7; 278657.9 ng*hr/dL
Summary
Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks |
150445.2; 70955.7; 278657.9 | — |
| PRIMARY The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks |
1345.6; 622.4; 261.9 | — |
| PRIMARY The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks |
895.5; 422.4; 1658.7 | — |
| SECONDARY Number of Patients in the PK Parameter Category |
10; 12; 3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01887418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.