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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: Completed Phase 4 study of Benign Prostatic Hyperplasia (BPH), sponsored by Siami, Paul F., M.D..
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tolterodine ER 4mg
- DRUG Pre-randomization Dutasteride
Study Locations (1)
Indiana
- Deaconess Clinic Gateway Health Center - Newburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2009-07 |
| Est. Completion | 2014-09 |
| Phase | Phase 4 |
What the finished NCT00939120 record still lists
NCT00939120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 99-participant average among 3 other Benign Prostatic Hyperplasia (BPH) trials with a reported enrollment target (54% lower).
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 a single indexed study location in 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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