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NCT03297398 · ClinicalTrials.gov registry record · Phase 2
Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
A Phase 2 study, sponsored by OPKO Health.
- Terminated
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
NCT03297398: Clinical Trial Phase 2 study, sponsored by OPKO Health.
NCT03297398 is a Phase 2 study that was terminated before completion, run by OPKO Health. The registered enrollment target is 114 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03297398, a Phase 2 study, was terminated before completion, sponsored by OPKO Health.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
Study Summary
This study will evaluate the safety and effectiveness of different doses of OPK-88004 compared to placebo on serum PSA compared to placebo in men with benign prostatic hyperplasia (BPH).
Primary Outcome
The trial will evaluate the effect of two doses of OPK-88004 (15 mg and 25 mg) daily for 16 weeks on serum PSA compared with placebo
Interventions
- OTHER Placebo
- DRUG Group-1 (15mg, OPK-88004)
- DRUG Group-2 (25 mg,OPK-88004)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2018-02-21 |
| Est. Completion | 2019-06-10 |
| Phase | Phase 2 |
Why NCT03297398 stopped before completion
NCT03297398 is an interventional study that assigns participants to a tested intervention. The registered 114 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 (14% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03297398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03297398 about?
NCT03297398 is a clinical study titled "Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)". This study will evaluate the safety and effectiveness of different doses of OPK-88004 compared to placebo on serum PSA compared to placebo in men with benign prostatic hyperplasia (BPH).
What is the current status of trial NCT03297398?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2018-02-21. Estimated completion is 2019-06-10.
What interventions are being tested in trial NCT03297398?
The interventions under investigation include: Placebo (OTHER), Group-1 (15mg, OPK-88004) (DRUG), Group-2 (25 mg,OPK-88004) (DRUG).
Who is sponsoring clinical trial NCT03297398?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03297398's enrollment target sits among peer trials
114 627th of 2000 higher than 1,370 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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