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NCT01489813 · ClinicalTrials.gov registry record · Phase 2
Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment
A Phase 2 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01489813: Completed Phase 2 study, sponsored by Emory University.
NCT01489813 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01489813, a Phase 2 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
Patients with non-invasive bladder cancer are often treated with intravesical therapy in order to prevent the recurrence of bladder cancer. Intravesical therapy can cause many lower urinary tract symptoms, which can limit the dose of therapy and therefore efficacy of treatment. There have been a number of studies that suggest a chemical found in soy beans may be able to help with these side effects. This chemical is called genistein and can be extracted and given to study subjects in pill form. In this study, the investigators would like to have patients placed into two different groups. One group would take genistein and the other group would take a placebo, a sugar pill that looks like the genistein pill. In doing this study the investigators hope to explore the findings from other studies to see if lower urinary tract symptoms are reduced and to see if recurrence rates for patients are affected by genistein. The study would take about four and a half months total.
Primary Outcome
The change in severity of urinary symptoms as determined by the International Prostate Symptom Score (IPSS) questionnaire score. IPSS scores at 6 weeks of treatment will be compared to scores at baseline of treatment. Lower values indicate a better outcome. 0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms
Interventions
- DRUG Sugar pill
- DRUG Genistein
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2017-05-19 |
| Est. Completion | 2024-08-31 |
| Phase | Phase 2 |
What the finished NCT01489813 record still lists
NCT01489813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Sugar pill is the first listed.
NCT01489813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01489813 about?
NCT01489813 is a clinical study titled "Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment". Patients with non-invasive bladder cancer are often treated with intravesical therapy in order to prevent the recurrence of bladder cancer. Intravesical therapy can cause many lower urinary tract symptoms, which can limit the dose of therapy and therefore efficacy of treatment. There have been a num...
What is the current status of trial NCT01489813?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2017-05-19. Estimated completion is 2024-08-31.
What interventions are being tested in trial NCT01489813?
The interventions under investigation include: Sugar pill (DRUG), Genistein (DRUG).
Who is sponsoring clinical trial NCT01489813?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01489813's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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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