Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms
NCT ID: NCT02252367
Last Updated: 2021-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
86 participants
INTERVENTIONAL
2015-12-31
2020-06-30
Brief Summary
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Aim of present study is to assess, for the first time in literature, changes in pressure flow study (PFS) and changes in molecular profile of prostatic tissue (inflammatory and tissue remodeling markers) in men treated for 12 weeks with tadalafil 5 mg compared with placebo and to correlate these data with changes in symptoms scores (IPSS, International Prostatic Symptoms Score) in men with LUTS secondary to BPH refractory to alpha blockers.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tadalafil
43 male subjects affected by BPH (benign prostatic hyperplasia) planned for simple prostatectomy will be randomized to tadalafil 5 mg - 1 film-coated tablet orally once daily for 12 weeks.
Tadalafil
Tadalafil 5 mg once daily for 12 weeks.
Placebo
43 male subjects affected by BPH (benign prostatic hyperplasia) planned for simple prostatectomy will be randomized to placebo.
Placebo
Placebo tablet once daily for 12 weeks.
Interventions
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Tadalafil
Tadalafil 5 mg once daily for 12 weeks.
Placebo
Placebo tablet once daily for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* treatment with alpha-blockers (Tamsulosin 0.4 mg/die)
* being capable of giving informed consent.
Exclusion Criteria
* known or suspected presence of prostatic cancer or PSA (prostate specific antigen) value \>10 ng/mL;
* suspected lack of the participant's compliance;
* known severe allergies or hypersensitivity to the study drug (active substance or excipients of the formulation);
* nown neurogenic bladder (i.e. Parkinson's disease);
* suspected or proven urinary infections;
* presence of bladder stone.
18 Years
MALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
University of Florence
OTHER
Responsible Party
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Mario Maggi
Full Professor of Endocrinology
Principal Investigators
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Mario Maggi
Role: PRINCIPAL_INVESTIGATOR
University of Florence
Locations
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Clinica Urologica - Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Countries
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References
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Gacci M, Corona G, Salvi M, Vignozzi L, McVary KT, Kaplan SA, Roehrborn CG, Serni S, Mirone V, Carini M, Maggi M. A systematic review and meta-analysis on the use of phosphodiesterase 5 inhibitors alone or in combination with alpha-blockers for lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol. 2012 May;61(5):994-1003. doi: 10.1016/j.eururo.2012.02.033. Epub 2012 Feb 25.
Gacci M, Vittori G, Tosi N, Siena G, Rossetti MA, Lapini A, Vignozzi L, Serni S, Maggi M, Carini M. A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Sex Med. 2012 Jun;9(6):1624-33. doi: 10.1111/j.1743-6109.2012.02718.x. Epub 2012 Apr 17.
Other Identifiers
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ANDRO-AOUC-2014-01
Identifier Type: -
Identifier Source: org_study_id
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