Clinical Trial in Males With BPH (Enlarged Prostate)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Benign Prostatic Hypertrophy; Urinary Retention; Prostatic Hyperplasia

Treatments: Drug: Alfuzosin (SL770499)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00029822

SL770499

EFC4485

Details and patient eligibility

About

A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH.

• Free study-related medical care provided.

Enrollment: 1,522 patients

Sex: Male

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Has been suffering for at least 6 months with any of the following symptoms:
• daytime or nighttime urinary frequency
• urgent feeling to urinate
• difficulty starting urinary stream
• interruption of urinary stream
• feeling of incomplete urination
• Has not had a previous episode of acute urinary retention
• Has not been diagnosed with prostate cancer
• Has not had previous prostate surgery
• Is not an insulin-dependent diabetic

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind