Phase 3
Completed N=524
Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
Hypogonadism · Primary Hypogonadism · Secondary Hypogonadism
Source: ClinicalTrials.gov NCT00467870 ↗
Enrolled (actual)
524
Serious AEs
14.3%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C — 94.0 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C |
94.0 | — |
| PRIMARY Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C |
494.9373 | — |
| PRIMARY Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C |
890.583 | — |
| PRIMARY Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C |
323.522 | — |
| PRIMARY Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C |
96.2 | — |
| PRIMARY Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C |
514.2792 | — |
| PRIMARY Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C |
837.648 | — |
| PRIMARY Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C |
342.800 | — |
| PRIMARY Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2 |
95.7; 0; 0 | — |
| PRIMARY Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2 |
449.6455 | — |
| PRIMARY Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2 |
689.002 | — |
| PRIMARY Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2 |
317.419 | — |
| SECONDARY Serum Total Testosterone Maximum Concentration in Part A |
805.867; 1023.591 | — |
| SECONDARY Serum Total Testosterone Maximum Concentration in Part B |
986.364; 1047.739 | — |
| SECONDARY Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C |
92.3; 0; 0 | — |
| SECONDARY Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 3rd Injection Interval in Part C |
51.3 | — |
| SECONDARY Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C |
94.9 | — |
| SECONDARY Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C |
50.2 | — |
| SECONDARY Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C |
53.8 | — |
| SECONDARY Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C |
92.3; 7.7; 0; 0 | — |
| SECONDARY Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C |
92.3; 3.8; 0 | — |
| SECONDARY Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 4th Injection Interval in Part C |
37.5 | — |
| SECONDARY Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C |
96.2 | — |
| SECONDARY Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C |
60.6 | — |
| SECONDARY Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C |
62.5 | — |
| SECONDARY Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C |
92.3; 3.8; 3.8; 0 | — |
| SECONDARY Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C |
82.6; 17.4; 0; 80.0; 17.4; 2.6 | — |
| SECONDARY Change in Body Mass Index From Baseline to Week 24 in Part C |
0.023 | — |
| SECONDARY Change in Weight From Baseline to Week 24 in Part C |
0.06 | — |
| SECONDARY Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2 |
8.7; 4.3; 4.3; 60.9 | — |
| SECONDARY Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 |
180.33; 301.85; 322.74; 332.92; 324.74; 230.71 | — |
| SECONDARY Serum Total Testosterone Concentrations in Part C2 |
197.629; 210.363; 254.669; 578.419; 606.484; 580.614 | — |
| SECONDARY Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 |
100.0; 0; 91.3; 0; 78.3; 0 | — |
| SECONDARY Trough Assessments of Serum Total Testosterone Concentrations in Part C2 |
197.629; 210.363; 254.669; 317.419; 316.215; 374.698 | — |
| SECONDARY Serum Total Testosterone Maximum Concentration in Part C2 |
711.343 | — |
Eligibility Criteria
Inclusion Criteria
- Male with primary or secondary hypogonadism at least 18 years of age and for study part C2 weighs ≥143.3 lb (≥65 kg)
- Morning screening serum testosterone concentration 4 ng/mL or hyperplasia of the prostate (size >75 cm3 as measured by transrectal ultrasonography)
- Past or present liver tumors or acute or chronic hepatic disease with impairment of liver function; liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) exceeding 1.5 times upper limit of normal
- History of deep vein thrombosis in the past 5 years or any history of cerebrovascular accident
- Severe acne
- Hypertension (systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm Hg) or coronary heart disease not stabilized by therapy as assessed by the investigator
- Insulin-dependent diabetes mellitus or uncontrolled non-insulin-dependent diabetes mellitus; patients with diabetes are excluded if screening glycated hemoglobin (HbA1C) level is >9%
- Use of any sex hormones within 28 days (for injectable testosterone preparations) or 7 days (for oral, gel, patch, etc, testosterone preparations) prior to screening visit and throughout the study (exclusive of administered study drug)
- Use of steroidal anabolic drugs or supplements (eg, dehydroepiandrosterone [DHEA]) by any application method within the 28 days prior to first administration of study drug and throughout the study (exclusive of administrated study drug)
- Medication with substances which might interfere with testosterone metabolism within 28 days before the first administration of study drug
- History of sleep apnea Insulin-dependent diabetes mellitus
- Use of steroidal anabolic drugs or supplements by any application method within the 28-days prior to the first administration of the study drug and throughout the study (exclusive of the administered study drug)
Data sourced from ClinicalTrials.gov (NCT00467870). 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.