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NCT00603304 · ClinicalTrials.gov registry record · Phase 3
Complementary and Alternative Medicine for Urological Symptoms(CAMUS)
A Phase 3 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 3
- Development phase
- 369
- Enrollment target
NCT00603304: Completed Phase 3 study, sponsored by University of Alabama at Birmingham.
NCT00603304 is a Phase 3 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 369 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00603304, a Phase 3 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 369 participants
- Enrollment target
Study Summary
The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the CAMUS trial will be given one out of two possible treatments at random. One out of every two men would get an inactive placebo treatment. One out of every two men would get Saw palmetto pills. This kind of scientific study is the best way to find out if the plant extracts really work to prevent men with benign prostatic hyperplasia (BPH) from getting worse. During the study, men will not know which of the two treatments they are assigned to. They will be followed very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial will be studied over 72 weeks. Tests and all medications needed as part of the study will be provided at no charge to the participant. Participants will be responsible for all other costs not associated with the study tests and medications. All information on study participants will be held in the strictest confidence and no one would have access to patient information other than the required authorized health care and research personnel.
Primary Outcome
The primary outcome was the mean difference in the AUA Symptom Score between baseline and 72 weeks between the saw palmetto and placebo groups. The AUA Symptom Score index is a seven item questionnaire assessing the frequency of lower urinary tract symptoms (LUTS). The questions are scored on a scale of zero to five, with zero being never, one to four being one to four accordingly, and five equaling five or more times. A Symptom Index is determined by adding the scores. The lowest possible score
Interventions
- DRUG Saw Palmetto - first 24 weeks
- DRUG Placebo - first 24 weeks
- DRUG Saw Palmetto - weeks 24 - 48
- DRUG Placebo - weeks 24 - 48
- DRUG Saw Palmetto - weeks 48 - 72
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 369 participants |
| Start Date | 2008-02 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
What the finished NCT00603304 record still lists
NCT00603304 is an interventional study that assigns participants to a tested intervention. The registered 369 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 (52% lower).
The record links to 0 conditions, and to 5 interventions - of which Saw Palmetto - first 24 weeks is the first listed.
NCT00603304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00603304 about?
NCT00603304 is a clinical study titled "Complementary and Alternative Medicine for Urological Symptoms(CAMUS)". The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the CAMUS trial will be given one out of two possible treatments at random. One out of every two men would get an inactive placebo treatment. One out of every two men would get Saw palmetto pills. This kind of sci...
What is the current status of trial NCT00603304?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 369 participants. The study started on 2008-02. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00603304?
The interventions under investigation include: Saw Palmetto - first 24 weeks (DRUG), Placebo - first 24 weeks (DRUG), Saw Palmetto - weeks 24 - 48 (DRUG), Placebo - weeks 24 - 48 (DRUG), Saw Palmetto - weeks 48 - 72 (DRUG).
Who is sponsoring clinical trial NCT00603304?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00603304's enrollment target sits among peer trials
369 995th of 2000 higher than 1,005 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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