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NCT00354432 · ClinicalTrials.gov registry record · Phase 3
Soy Protein/Effexor Hormone Therapy for Prostate Cancer
A Phase 3 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
NCT00354432: Clinical Trial Phase 3 study, sponsored by Wake Forest University Health Sciences.
NCT00354432 is a Phase 3 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 120 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00354432, a Phase 3 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
Study Summary
RATIONALE: Soy protein/isoflavones and venlafaxine may help relieve hot flashes in patients receiving hormone therapy for prostate cancer. It is not yet known whether soy protein/isoflavones are more effective than venlafaxine when given together or with a placebo in treating hot flashes. PURPOSE: This randomized phase III trial is studying soy protein/isoflavones and venlafaxine to compare how well they work when given together or with a placebo in treating hot flashes in patients receiving hormone therapy for prostate cancer.
Primary Outcome
The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i
Interventions
- DRUG Placebo Pill
- DIETARY_SUPPLEMENT Placebo Powder
- DRUG Venlafaxine
- DIETARY_SUPPLEMENT oral soy protein/isoflavones powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2007-02-01 |
| Est. Completion | 2010-08-01 |
| Phase | Phase 3 |
Why NCT00354432 stopped before completion
NCT00354432 is an interventional study that assigns participants to a tested intervention. The registered 120 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 (84% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo Pill is the first listed.
NCT00354432 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00354432 about?
NCT00354432 is a clinical study titled "Soy Protein/Effexor Hormone Therapy for Prostate Cancer". RATIONALE: Soy protein/isoflavones and venlafaxine may help relieve hot flashes in patients receiving hormone therapy for prostate cancer. It is not yet known whether soy protein/isoflavones are more effective than venlafaxine when given together or with a placebo in treating hot flashes. PURPOSE: ...
What is the current status of trial NCT00354432?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2007-02-01. Estimated completion is 2010-08-01.
What interventions are being tested in trial NCT00354432?
The interventions under investigation include: Placebo Pill (DRUG), Placebo Powder (DIETARY_SUPPLEMENT), Venlafaxine (DRUG), oral soy protein/isoflavones powder (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00354432?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00354432's enrollment target sits among peer trials
120 1619th of 2000 higher than 361 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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