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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 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 310 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00626431
The ClinicalTrials.gov registry entry for NCT00626431 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott, which has 181 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Leuprolide acetate - Formulation A is the first listed.
NCT00626431 reports 0 study locations.
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.
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