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NCT00467870 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
A Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 531
- Enrollment target
NCT00467870: Completed Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT00467870 is a Phase 3 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 531 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00467870, a Phase 3 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 531 participants
- Enrollment target
Study Summary
To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.
Primary Outcome
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.
Interventions
- DRUG Testosterone Undecanoate 750 mg
- DRUG Testosterone Undecanoate 1000 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 531 participants |
| Start Date | 2006-03 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
What the finished NCT00467870 record still lists
NCT00467870 is an interventional study that assigns participants to a tested intervention. The registered 531 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which Testosterone Undecanoate 750 mg is the first listed.
NCT00467870 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00467870 about?
NCT00467870 is a clinical study titled "Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men". To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.
What is the current status of trial NCT00467870?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 531 participants. The study started on 2006-03. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00467870?
The interventions under investigation include: Testosterone Undecanoate 750 mg (DRUG), Testosterone Undecanoate 1000 mg (DRUG).
Who is sponsoring clinical trial NCT00467870?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00467870's enrollment target sits among peer trials
531 704th of 2000 higher than 1,295 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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