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Clinical trialNCT00451191CompletedPhase 2Interventional

Botulinum Toxin Injection for the Management of BPH

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrollment134Benign Prostatic Hyperplasia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a double-blind randomized phase II trial to determine whether two different doses of BoNT/A injection into the prostate gland demonstrate sufficient improvement in the management of lower urinary symptoms due to BPH to warrant more extensive research. Subjects will receive either a 100U or 300U dose. Participation will last 1 year.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Colorado Health Sciences Center

    Denver, Colorado, United States

  • Northwestern University

    Chicago, Illinois, United States

  • Mayo Clinic

    Rochester, Minnesota, United States

  • Cornell University

    New York, New York, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, United States

  • Baylor College of Medicine

    Houston, Texas, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Botulinum toxin type A →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Oct 2006
Primary completion
30 Jun 2009
Completion
31 Dec 2009
Last update posted
21 Apr 2020
Registered enrollment
134
Registry id
NCT00451191
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.