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Questioning Patients About Adverse Medical Events

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

Benign Prostatic Hyperplasia

Study type

Observational

Funder types

Other

Identifiers

NCT00187616
STEPAE-001

Details and patient eligibility

About

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.

Full 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).

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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