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)

NCT04831476 | Completed

• 1 other identifier: 2020-DTM-EL-126/133
• Study Type: observational
• Target: 1,296
• Locations: 1 country
• Sites: 1

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 benign prostatic hyperplasia (BPH) in treatment with a stable combination of dutasteride and tamsulosin (Dinaplex®)

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostate Hyperplasia; IPSS (International Prostate Symptom Score); LUTS (Lower Urinary Tract Symptoms)

Outcome Measures

Primary Outcomes (1)

• Evaluation of disease control (BPH), PROSPERITY I Evaluation of quality of life. PROSPERITY II

  The change in the overall score (questions 1-7) of the IPSS (International Prostate Symptom Score) questionnaire. PROSPERITY I. The change in the score of the question related to quality of life, of the IPSS questionnaire. PROSPERITY II

  3-6 months

Secondary Outcomes (3)

• Evaluation of disease control (BPH), PROSPERITY II.

  3-6 months

• U/S measurement. PROSPERITY I&II

  3-6 months

• Number of AEs (PROSPERITY I&II)

  3-6 months

Interventions

Patients with Benign Prostate Hyperplasia OTHER

patients with benign prostatic hyperplasia under fixed dose combΙnation treatment with dutasteride and tamsulosin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult males who based on physician's recommedations will receive DINAPLEX®- Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride (equivalent to 0.367 mg tamsulosin) Tamsulosin hydrochloride Tamsulosin binds selectively and competitively to postsynaptic α1A adrenergic receptors and to a lesser extent to α1D adrenergic receptors. It relaxes the smooth muscles of the prostate and urethra. By relaxing the smooth muscle fibers of the bladder sphincter, it relieves obstructive effects and increases urine flow. It has little antihypertensive effect. Doutasteride Dutasteride lowers circulating dihydrotestosterone (DHT) levels by inhibiting the 5a-reductase isoenzymes type I and II, which are responsible for converting testosterone to DHT. The effect of dutasteride on DHT levels is dose-dependent and is observed within 1-2 weeks (85% and 90% reduction respectively).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

Laikon Hospital of Athens

Athens, Greece

Location

Related Publications (23)

• World Medical Association Declaration of Helsinki. Ethical principles for Medical Research Involving Human Subjects, Helsinki 1964, amended in Tokyo 1975, Venice 1983, Hong Kong 1989, South Africa 1996, Edinburgh 2000, and Seoul 2008.

  BACKGROUND

• Helga Fritch, Wolfgang Kühnel. Εγχειρίδιο Περιγραφικής Ανατομικής. s.l. : Π.Χ. Πασχαλίδης, 2009.

  RESULT

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  RESULT

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  PMID: 8832064 RESULT

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  PMID: 11111208 RESULT

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  PMID: 11832306 RESULT

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  PMID: 7515446 RESULT

• Sidney S, Quesenberry CP Jr, Sadler MC, Guess HA, Lydick EG, Cattolica EV. Incidence of surgically treated benign prostatic hypertrophy and of prostate cancer among blacks and whites in a prepaid health care plan. Am J Epidemiol. 1991 Oct 15;134(8):825-9. doi: 10.1093/oxfordjournals.aje.a116157.

  PMID: 1719806 RESULT

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  PMID: 12121722 RESULT

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  PMID: 9465938 RESULT

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  PMID: 7683816 RESULT

• Ryl A, Rotter I, Miazgowski T, Slojewski M, Dolegowska B, Lubkowska A, Laszczynska M. Metabolic syndrome and benign prostatic hyperplasia: association or coincidence? Diabetol Metab Syndr. 2015 Oct 29;7:94. doi: 10.1186/s13098-015-0089-1. eCollection 2015.

  PMID: 26516352 RESULT

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• International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50. No abstract available.

  PMID: 11590294 RESULT

• Epstein M; International Society of Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2005 Aug;14(8):589-95. doi: 10.1002/pds.1082. No abstract available.

  PMID: 15918159 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 5, 2021
• Study Start: September 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: October 18, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)