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NCT00962390 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of S-Equol on Men With Benign Prostatic Hyperplasia
A Phase 2 study, sponsored by Ausio Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
NCT00962390: Completed Phase 2 study, sponsored by Ausio Pharmaceuticals.
NCT00962390 is a Phase 2 study that has completed, run by Ausio Pharmaceuticals. The registered enrollment target is 116 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00962390, a Phase 2 study, has completed, sponsored by Ausio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and effectiveness of S-equol in men with benign prostatic hyperplasia.
Primary Outcome
Prostate specific antigen is considered to be the most sensitive measure of S-equol effects on the prostate, due to the expected effects of S-equol on the androgen receptor axis. In this proof-of-concept study, a population of 124 male subjects was estimated to achieve approximately 104 completed subjects (based on an estimated drop-out rate of 15%) to examine the dose-response compared to placebo. A sample size of 26 subjects in each treatment arm was considered to be adequate to observe a tren
Interventions
- DRUG Placebo
- DRUG S-equol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2009-06 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
What the finished NCT00962390 record still lists
NCT00962390 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00962390 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00962390 about?
NCT00962390 is a clinical study titled "Efficacy and Safety of S-Equol on Men With Benign Prostatic Hyperplasia". The purpose of this study is to assess the safety and effectiveness of S-equol in men with benign prostatic hyperplasia.
What is the current status of trial NCT00962390?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2009-06. Estimated completion is 2016-01.
What interventions are being tested in trial NCT00962390?
The interventions under investigation include: Placebo (DRUG), S-equol (DRUG).
Who is sponsoring clinical trial NCT00962390?
This trial is sponsored by Ausio Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00962390's enrollment target sits among peer trials
116 623rd of 2000 higher than 1,375 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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