Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00939120

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

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Study of Safety and Efficacy of Dutasteride in Combination With Tolterodine ER or Placebo in Men With Lower Urinary Tract Symptoms (LUTS) Including Urgency and Frequency

Clinical Trial 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).

Clinical Trial Description

Men who are treated with an alpha blocker (AB) or 5-alpha reductase inhibitor (5-ARI) for benign prostatic enlargement (BPE) and lower urinary tract symptoms (LUTS) often have symptoms including urinary frequency and urgency. ABs and 5-ARIs may improve the obstructive voiding symptoms but not necessarily the storage symptoms.

This study will evaluate the safety and efficacy of dutasteride 0.5 mg once daily for 6 months in an open label fashion. Those patients who continue to report storage urinary symptoms, will be randomized to receive dutasteride 0.5 mg once daily for an additional one year together with double-blind tolterodine ER 4 mg or matched tolterodine ER placebo once daily. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00939120
Study type Interventional
Source Siami, Paul F., M.D.
Contact
Status Completed
Phase Phase 4
Start date July 2009
Completion date September 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT03052049 - Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres N/A
Recruiting NCT04757116 - Post-Market Study to Assess iTind Safety in Comparison to UroLift N/A
Completed NCT03460873 - Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate
Completed NCT01218243 - An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia Phase 2
Completed NCT01566292 - Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy Phase 2/Phase 3
Active, not recruiting NCT00407953 - PROLIEVE® Post-Marketing Study TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) Phase 4
Completed NCT03191734 - French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue N/A
Recruiting NCT04838769 - REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men N/A
Completed NCT03856242 - Benign Prostatic Hyperplasia and Ischemic Heart DIsease Phase 4
Completed NCT04032067 - Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH) Phase 3
Completed NCT02505919 - Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER) N/A
Completed NCT02855892 - A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH Phase 2
Completed NCT02145208 - Study to Assess the Efficacy of Medi-Tate iTind Device N/A
Completed NCT00970632 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Phase 3
Recruiting NCT02592473 - Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia N/A
Completed NCT00945490 - Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018 Phase 3
Completed NCT00759135 - Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate) Phase 2
Completed NCT00224107 - A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo Phase 3
Recruiting NCT04648176 - Application of MOSES Technology in BPH N/A
Terminated NCT00651807 - A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806) Phase 2