Status:
COMPLETED
Α Prospective Observational Study for the Evaluation of Disease Control and Quality of Life in Patients With Benign PROStatic hyPERplasia Under Fixed Dose combΙnaTion Treatment With Dutasteride and Tamsulosin . PROSPERITY Group of Studies (I&II)
Lead Sponsor:
Elpen Pharmaceutical Co. Inc.
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
18-85 years
Brief Summary
Investigation of the efficacy and safety of the stable combination of dutasteride and tamsulosin (Dinaplex®) in the Greek population as well as the evaluation of the quality of life of patients with b...
Detailed Description
Combination therapy with the 5-α reductase inhibitor, dutasteride, and the α-blocker, tamsulosin, in men with moderate to severe benign prostatic hyperplasia and prostate enlargement, was studied in t...
Eligibility Criteria
Inclusion
- Adult male patient with moderate to severe BPH symptoms receiving either monotherapy, dual medication as monoproducts or other stable combination and not responding adequately to treatment.
- Adult male patient with BPH who has fully understood the study procedures and has signed a consent form after information.
Exclusion
- Patient who does not meet the criteria for taking the study drug (s), according to the Summary of Product Characteristics of each drug in the study.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
1296 Patients enrolled
Trial Details
Trial ID
NCT04831476
Start Date
September 1 2021
End Date
October 31 2022
Last Update
October 18 2023
Active Locations (1)
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1
Laikon Hospital of Athens
Athens, Greece