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NCT00626431 · ClinicalTrials.gov registry record · Phase 3
A Study of Leuprolide to Treat Prostate Cancer
A Phase 3 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 310
- Enrollment target
NCT00626431: Completed Phase 3 study, sponsored by Abbott.
NCT00626431 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 310 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00626431, a Phase 3 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 310 participants
- Enrollment target
Study Summary
To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to \<= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of the 2-sided 90% confidence interval), a protocol-specified criterion.
Primary Outcome
The percentage of subjects with testosterone suppression (\<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (\>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 4
Interventions
- DRUG Leuprolide acetate - Formulation A
- DRUG Leuprolide acetate - Formulation B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2008-02 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
What the finished NCT00626431 record still lists
NCT00626431 is an interventional study that assigns participants to a tested intervention. The registered 310 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 (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Leuprolide acetate - Formulation A is the first listed.
NCT00626431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00626431 about?
NCT00626431 is a clinical study titled "A Study of Leuprolide to Treat Prostate Cancer". To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to \<= 50 ng/d...
What is the current status of trial NCT00626431?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 310 participants. The study started on 2008-02. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00626431?
The interventions under investigation include: Leuprolide acetate - Formulation A (DRUG), Leuprolide acetate - Formulation B (DRUG).
Who is sponsoring clinical trial NCT00626431?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00626431's enrollment target sits among peer trials
310 1107th of 2000 higher than 892 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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