Trial · NCT00467870
Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
NCT00467870, Phase 3, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2017-03-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men. Trials, record NCT00467870. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00467870
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
- NCT number
- NCT00467870
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 531 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
- Interventions
- Testosterone Undecanoate 750 mg, Testosterone Undecanoate 1000 mg
- First posted
- 2007-05-01
- Last updated
- 2017-10-05
- Results first posted
- 2017-03-07
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | Responders were participants with serum total testosterone average concentration (Cavg) between 300 and 1000 ng/dL derived from the 3rd injection intensive pharmacokinetic (IPK) interval. |
| Primary | Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | Serum total testosterone Cavg derived from the 3rd injection IPK interval |
| Primary | Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | Serum total testosterone maximum concentration (Cmax) derived from the 3rd injection IPK interval |
| Primary | Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C | Day 70 post injection at week 14 | Serum total testosterone concentration at the end of the dosing interval (Ctrough) derived from the 3rd injection IPK interval |
| Primary | Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | Responders were participants with serum total testosterone Cavg between 300 and 1000 ng/dL derived from the 4th injection IPK interval. |
| Primary | Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | Serum total testosterone Cavg derived from the 4th injection IPK interval |
| Primary | Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | Serum total testosterone Cmax derived from the 4th injection IPK interval |
| Primary | Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C | Day 70 post injection at week 24 | Serum total testosterone Ctrough derived from the 4th injection IPK interval |
| Primary | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2 | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | Success was defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax \>2500 ng/dL. |
| Primary | Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2 | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | Serum total testosterone Cavg derived from the 2nd injection IPK interval |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | Pharmacokinetic (PK) population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | percentage of participants | NUMBER |
| PRIMARY | Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | ng/dL | MEAN |
| PRIMARY | Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | ng/dL | MEAN |
| PRIMARY | Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C | Day 70 post injection at week 14 | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | ng/dL | MEAN |
| PRIMARY | Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis) | percentage of participants | NUMBER |
| PRIMARY | Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis) | ng/dL | MEAN |
| PRIMARY | Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis) | ng/dL | MEAN |
| PRIMARY | Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C | Day 70 post injection at week 24 | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis) | ng/dL | MEAN |
| PRIMARY | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2 | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded) | percentage of participants | NUMBER |
| PRIMARY | Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2 | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded) | ng/dL | MEAN |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C | C-TU 750 mg | 94.0 | 95% Confidence Interval 89.7 to 98.3 | percentage of participants | |
| Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C | C-TU 750 mg | 494.9373 | Standard Deviation 141.46351 | ng/dL | |
| Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C | C-TU 750 mg | 890.583 | Standard Deviation 345.1148 | ng/dL | |
| Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C | C-TU 750 mg | 323.522 | Standard Deviation 99.1081 | ng/dL | |
| Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C | C-TU 750 mg | 96.2 | 95% Confidence Interval 92.5 to 99.8 | percentage of participants | |
| Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C | C-TU 750 mg | 514.2792 | Standard Deviation 163.11476 | ng/dL | |
| Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C | C-TU 750 mg | 837.648 | Standard Deviation 412.0692 | ng/dL | |
| Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C | C-TU 750 mg | 342.800 | Standard Deviation 106.9180 | ng/dL | |
| Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2 | C2-TU 750 mg | Cmax ≤1500 ng/dL | 95.7 | percentage of participants | |
| Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2 | C2-TU 750 mg | Cmax 1800-2500 ng/dL | 0 | percentage of participants |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A-TU 750 mg | 120 | |
| Overall Study | STARTED | A-TU 1000 mg | 117 | |
| Overall Study | STARTED | B-TU 750 mg | 22 | |
| Overall Study | STARTED | B-TU 1000 mg | 112 | |
| Overall Study | STARTED | C-TU 750 mg | 130 | |
| Overall Study | STARTED | C2-TU 750 mg | 23 | |
| Overall Study | COMPLETED | A-TU 750 mg | 75 | |
| Overall Study | COMPLETED | A-TU 1000 mg | 74 | |
| Overall Study | COMPLETED | B-TU 750 mg | 18 | |
| Overall Study | COMPLETED | B-TU 1000 mg | 79 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events194
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Sinusitis | Infections and infestations | TU 750 mg | 18 | 272 | |
| other | Sinusitis | Infections and infestations | TU 1000 mg | 13 | 252 | |
| other | Upper respiratory tract infection | Infections and infestations | TU 750 mg | 15 | 272 | |
| other | Upper respiratory tract infection | Infections and infestations | TU 1000 mg | 15 | 252 | |
| other | Nasopharyngitis | Infections and infestations | TU 750 mg | 14 | 272 | |
| other | Nasopharyngitis | Infections and infestations | TU 1000 mg | 14 | 252 | |
| other | Bronchitis | Infections and infestations | TU 750 mg | 12 | 272 | |
| other | Bronchitis | Infections and infestations | TU 1000 mg | 8 | 252 | |
| other | Urinary tract infection | Infections and infestations | TU 750 mg | 5 | 272 | |
| other | Urinary tract infection | Infections and infestations | TU 1000 mg | 9 | 252 |
1 to 10 of 194Source ClinicalTrials.gov
See all 194 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TU 750 mg | ||
| Total, all-cause mortality | TU 1000 mg | ||
| Total, other adverse events | TU 750 mg | 131 | 272 |
| Total, other adverse events | TU 1000 mg | 120 | 252 |
| Total, serious adverse events | TU 750 mg | 38 | 272 |
| Total, serious adverse events | TU 1000 mg | 37 | 252 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| TU 750 mg vs TU 1000 mg: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00467870
GET https://conductscience.org/api/trials/v1/NCT00467870/registered?page=2