Trial · NCT00467870
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| 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 |
| Primary | Serum Total Testosterone Maximum 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 Cmax derived from the 2nd injection IPK interval |
| Primary | Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2 | Day 70 post injection at week 4 | Serum total testosterone Ctrough derived from the 2nd injection IPK interval |
| Secondary | Serum Total Testosterone Maximum Concentration in Part A | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 1, week 12, week 24, and week 36; and post injection at weeks 48, 60, 72, 84, 96, 108, and 120 | |
| Secondary | Serum Total Testosterone Maximum Concentration in Part B | Post injection at week 1; post injection at week 8; days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 20; and post injection at weeks 32, 44, 56, 68, and 80 | |
| Secondary | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success 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 | Success is 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. |
| 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 | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | |
| Secondary | Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL 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 | |
| Secondary | Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | |
| Secondary | Percentage of Participants With Clinical Success 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 | Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL |
| 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 | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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