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NCT00690950 Clinical Trial

A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Switch Study: Are There Any Measurable Differences When Switching Patients on Finasteride Therapy to Dutasteride?

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00690950
Other study ID # 110895
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received June 3, 2008
Last updated June 4, 2008
Start date May 2008

Study information
Verified date June 2008
Source Urologic Consultants of Southeastern PA
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Hypothesis: Dutasteride will perform better than finasteride in decreasing prostate volume, improving symptoms based on International Prostate Symptom score,and lower pvr based on the scientific information that dutasteride inhibits both Type I and II 5-alpha-reducatase vs. finasteride which only inhibits the Type II enzyme

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 50
Est. completion date
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- Male

- Age 50-80

- On finasteride for no less than 12 months

- Willing to undergo all necessary test in the 12 month evaluation

Exclusion Criteria:

- History of medication non-compliance

- Unwillingness to undergo/tolerate 2 blood draws

- Unwillingness to tolerate/undergo 2 TRUSP

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Dutasteride
0.5mg capsule, taken once daily for 12 months

Locations
Country Name City State
United States Urologic Consultants of Southeastern PA Bala Cynwyd Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Urologic Consultants of Southeastern PA

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Laboratory parameters: including serum testosterone, DHT level and PSA 12 months No
Secondary volume measurements of TRUSP and PVR 12 months No
Secondary A decrease in the AUASI 12 months No
See also
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Recruiting NCT04288427 - 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy N/A
Not yet recruiting NCT04245566 - Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH Phase 3
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Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
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Completed NCT02283684 - GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT Phase 4
Completed NCT01438775 - Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) Phase 3
Completed NCT01454349 - Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH) Phase 1/Phase 2
Completed NCT01152190 - A Study in Benign Prostatic Hyperplasia Phase 3
Completed NCT01139762 - A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms Phase 3
Active, not recruiting NCT00400894 - Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma N/A
Completed NCT00701779 - Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia Phase 4
Unknown status NCT00381108 - Study of the Effects of Pomegranate Tablets on Enlarged Prostates Phase 1
Completed NCT00224133 - The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months Phase 3
Terminated NCT02962674 - To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH. N/A
Active, not recruiting NCT05415748 - Deprescribing Tamsulosin in Older Men Phase 4
Recruiting NCT04853914 - Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound. N/A

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