NCT00037154

Brief Summary

The purpose of this study is to test whether an extract of the saw palmetto plant is effective for relieving symptoms of Benign Prostatic Hyperplasia (BPH).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 1999

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2002

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

First QC Date

May 16, 2002

Last Update Submit

January 12, 2010

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic HyperplasiaHerbal TherapiesComplementary and Alternative MedicineMen's Health

Interventions

Saw PalmettoDRUG

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Eligibility Criteria: * Participants must be men, aged 50 years or older with moderate-to-severe BPH. * Participants must not have a history of prostate cancer, prior surgery on the prostate, kidney failure, or taking furosemide (Lasix), warfarin (Coumadin), or hormone medications. Individuals taking medicine for their BPH must stop them for one month (prazosin, terazosin (Hytrin), doxazosin (Cardura), tamsulosin (Flomax)) or six months (saw palmetto, finasteride (Proscar or Rogaine)) prior to entering the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Northern California Kaiser Permanente

Oakland, California, 94611, United States

Location

Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

Related Publications (2)

  • Bent S, Kane C, Shinohara K, Neuhaus J, Hudes ES, Goldberg H, Avins AL. Saw palmetto for benign prostatic hyperplasia. N Engl J Med. 2006 Feb 9;354(6):557-66. doi: 10.1056/NEJMoa053085.

    PMID: 16467543RESULT

  • Avins AL, Bent S, Padula A, Staccone S, Badua E, Goldberg H. Initial experience with a group presentation of study results to research participants. Trials. 2008 Mar 21;9:16. doi: 10.1186/1745-6215-9-16.

    PMID: 18355417DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

saw palmetto extract

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Andrew Avins, MD, MPH

    Northern California Kaiser Permanente; University of California, San Francisco; San Francisco Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

  • Stephen Bent, MD

    University of California, San Francisco; San Francisco Veterans Affairs Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 16, 2002

First Posted

May 17, 2002

Study Start

August 1, 1999

Study Completion

December 1, 2002

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations

US(2)