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NCT00939120 · ClinicalTrials.gov registry record · Phase 4

Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)

A Phase 4 study of Benign Prostatic Hyperplasia (BPH), sponsored by Siami, Paul F., M.D..

Completed
Registry status
Phase 4
Development phase
46
Enrollment target
1
Study location

NCT00939120 is a Phase 4 study of Benign Prostatic Hyperplasia (BPH) that has completed, run by Siami, Paul F., M.D.. The registered enrollment target is 46 participants, below the 99-participant average among 3 other Benign Prostatic Hyperplasia (BPH) trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00939120, a Phase 4 study of Benign Prostatic Hyperplasia (BPH), has completed, sponsored by Siami, Paul F., M.D..

COMPLETED
Registry status
Phase 4
Development phase
46 participants
Enrollment target
1
Study location

Study Summary

This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride given for 18 months, including a 1-year double-blind randomized co-administration with either tolterodine ER or placebo in men suffering from lower urinary tract symptoms (LUTS) including urgency and frequency, with or without urgency urinary incontinence (i.e., overactive bladder (OAB) symptoms).

Interventions

  • DRUG Placebo
  • DRUG Tolterodine ER 4mg
  • DRUG Pre-randomization Dutasteride

Study Locations (1)

Indiana

  • Deaconess Clinic Gateway Health Center - Newburgh

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2009-07
Est. Completion 2014-09
Phase Phase 4

Sponsor

Siami, Paul F., M.D.

2 total trials

What the Registry Record Tells You About NCT00939120

The ClinicalTrials.gov registry entry for NCT00939120 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 99-participant average among 3 other Benign Prostatic Hyperplasia (BPH) trials with a reported enrollment target (54% lower). The listed sponsor is Siami, Paul F., M.D., which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Benign Prostatic Hyperplasia (BPH) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00939120 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.

Frequently Asked Questions

What is clinical trial NCT00939120 about?

NCT00939120 is a clinical study titled "Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)". This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride given for 18 months, including a 1-year double-blind randomized co-administration with either tolterodine ER or placebo in men suffering from lower urinary tract symptoms (LUTS) including urgency and frequenc...

What is the current status of trial NCT00939120?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2009-07. Estimated completion is 2014-09.

What conditions does trial NCT00939120 study?

This clinical trial studies the following conditions: Benign Prostatic Hyperplasia (BPH).

What interventions are being tested in trial NCT00939120?

The interventions under investigation include: Placebo (DRUG), Tolterodine ER 4mg (DRUG), Pre-randomization Dutasteride (DRUG).

Who is sponsoring clinical trial NCT00939120?

This trial is sponsored by Siami, Paul F., M.D., which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00939120 being conducted?

This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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