CClinicalTrials.gg
CompletedNCT00187616Updated Jan 24, 2024

Questioning Patients About Adverse Medical Events

An observational study in Benign Prostatic Hyperplasia, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-01-24.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
214
Ages
50 Years and older
Sex
Male
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Study summary

This trial studies whether 3 different methods of asking patients about adverse medical events in a clinical trial affects the rate of reported side effects.

Read the detailed description

214 patients involved in a larger randomized controlled trial of the herb, saw palmetto, for benign prostatic hyperplasia were randomly assigned to 3 different methods of adverse event ascertainment after a 1-month placebo run-in visit. Two methods of ascertainment were open ended questions, and 1 was a checklist. Patients were blinded to group assignment, but investigators were aware (single blind). All patients had taken placebo for one month, but had been told it was a study drug (single blind).

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Conditions studied

  • Benign Prostatic Hyperplasia

Keywords

  • adverse events
  • clinical trial methodology
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In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 214 is close to the median of 214 across 167 observational studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Male, age > 49, American Urological Association Symptom Index > 8
  • Max urine flow rate > 4 and \< 15

Exclusion criteria

Exclusion Criteria:

  • prior prostate cancer or surgery
  • use of medications that affect urination
  • severe concomitant illness
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Study design

Time perspective
Prospective
Enrollment
214 participants
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Study locations

1 site
  • San Francisco VA Medical Center
    San Francisco, California 94121, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00187616
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Apr 2002
Completion
Apr 2003
Last update
Jan 24, 2024

Study contacts

Stephen Bent, MD
principal investigator · University of California, San Francisco
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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