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Clinical trials for BPH

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    56 result(s) found for: BPH. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2008-002841-21 Sponsor Protocol Number: H6D-MC-LVHJ(a) Start Date*: 2008-10-28
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of B...
    Medical condition: Benign Prostatic Hyperplasia (BPH)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004446 Benign prostatic hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-020604-29 Sponsor Protocol Number: H6D-CR-LVIW(a), Addendum 1 u.4 Start Date*: 2010-11-05
    Sponsor Name:Eli Lilly and Company Limited
    Full Title: A Phase 3b,randomized,double-blind,placebo-controlled parallel-design study to evaluate the efficacy and safety of tadalafil coadministered with finasteride for 6 months in men with lower urinary ...
    Medical condition: Benign Prostatic Hyperplasia (BPH)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10004446 Benign prostatic hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) FR (Completed) BE (Completed) IT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2009-010739-42 Sponsor Protocol Number: H6D-MC-LVID Start Date*: 2009-10-01
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men with Signs ...
    Medical condition: Benign Prostatic Hyperplasia (BPH)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004446 Benign prostatic hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) NL (Completed) BE (Completed) AT (Completed) IT (Completed) FR (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2007-003578-24 Sponsor Protocol Number: FE 200486 CS25 Start Date*: 2008-06-30
    Sponsor Name:Ferring Pharmaceuticals A/S
    Full Title: A single-centre, open-label, randomised explorative pharmacokinetic/pharmacodynamic study of the gonadotropin-releasing hormone receptor antagonist degarelix (FE 200486) in patients with benign pro...
    Medical condition: Patients with Benign Prostata Hypertropia (BPH) who fulfil the following criteria: a prostate volume of more than 30 mL, maximal uroflow of 12 mL/s or less; International Prostate Symptom Score (IP...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004447 Benign prostatic hypertrophy LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-020220-22 Sponsor Protocol Number: H6D-MC-LVIR Start Date*: 2010-12-21
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effect of Tadalafil Once Daily for 8 Weeks on Prostatic Blood Flow and Perfusion Parameters in Men with Signs and Symptoms of Be...
    Medical condition: Benign Prostatic Hyperplasia (BPH)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038604 - Reproductive system and breast disorders 10004446 Benign prostatic hyperplasia PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-004321-15 Sponsor Protocol Number: H6D-MC-LVHK(b) Start Date*: 2007-12-14
    Sponsor Name:Eli Lilly and Company Limited
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign P...
    Medical condition: Effects on urodynamic parameters in men with benign prostatic hyperplasia (also referred to as BPH-LUTS [lower urinary tract symptoms]) with and without urodynamic evidence of bladder outlet obstru...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004446 Benign prostatic hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000946-16 Sponsor Protocol Number: TryptoBPH Start Date*: 2021-12-17
    Sponsor Name:Centro Clínico Académico - Braga, Associação (2CA-Braga)
    Full Title: TryptoBPH - Proof-of-concept study to evaluate the safety and efficacy of tryptophan in patients with BPH
    Medical condition: Benign Prostate Hyperplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004872 10065030 BPH LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-005307-33 Sponsor Protocol Number: P00048GP403 Start Date*: 2012-09-24
    Sponsor Name:PIERRE FABRE MEDICAMENT
    Full Title: Exploratory study of L.S.E.S.r. (PERMIXON® 160 mg hard capsule) versus Tamsulosine LP activity on inflammation biomarkers in the treatment of urinary symptoms related to BPH, A multinational, multi...
    Medical condition: The aim of the proposed study is to assess the activity on inflammation biomarkers of L.S.E.S.r (PERMIXON® 160mg hard capsule) and Tamsulosine LP in the treatment of BPH. The potential links betwee...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038604 - Reproductive system and breast disorders 10004447 Benign prostatic hypertrophy LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (Completed) ES (Completed) IT (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000222-38 Sponsor Protocol Number: P00048GP404 Start Date*: 2014-06-03
    Sponsor Name:PIERRE FABRE MEDICAMENT
    Full Title: PERMIXON® 160 mg hard capsule versus placebo in the treatment of symptomatic lower urinary tract symptoms due to benign prostatic hyperplasia. Single-blind placebo run-in period then double-blin...
    Medical condition: PERMIXON® 160 mg hard capsule versus placebo in the treatment of symptomatic lower urinary tract symptoms due to benign prostatic hyperplasia.
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004872 10004447 Benign prostatic hypertrophy LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Completed) ES (Completed) CZ (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-002047-26 Sponsor Protocol Number: FDC116115 Start Date*: 2012-10-03
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: FDC116115: A prospective study of sexual function in sexually active men treated for BPH
    Medical condition: BPH (Benign prostatic hyperplasia)
    Disease: Version SOC Term Classification Code Term Level
    15.0 10038604 - Reproductive system and breast disorders 10038604 Reproductive system and breast disorders SOC
    15.0 10038604 - Reproductive system and breast disorders 10004446 Benign prostatic hyperplasia PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GR (Completed) NL (Completed) HU (Completed) ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-012325-11 Sponsor Protocol Number: FE 200486 CS36 Start Date*: 2009-10-21
    Sponsor Name:Ferring Pharmaceuticals A/S
    Full Title: A dose-finding, multi-centre, double-blind, randomised, parallel, placebo-controlled trial to investigate efficacy and safety of degarelix in men with lower urinary tract symptoms (LUTS) associated...
    Medical condition: Bening Prostate Hyperplasia
    Disease: Version SOC Term Classification Code Term Level
    12.0 10014840 Enlarged prostate (benign) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: CZ (Completed) GB (Completed) DK (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-022111-19 Sponsor Protocol Number: FDC114615 Start Date*: 2010-11-22
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: Study FDC114615: Comparative efficacy of DuodartTM plus lifestyle advice versus watchful waiting plus lifestyle advice with step-up therapy to tamsulosin in the management of treatment naïve men wi...
    Medical condition: Benign prostatic hyperplasia
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038604 - Reproductive system and breast disorders 10004446 Benign prostatic hyperplasia PT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed) ES (Completed) NL (Completed) GB (Completed) FR (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-002371-33 Sponsor Protocol Number: FS05-01 Start Date*: 2006-01-02
    Sponsor Name:Urologische Partnerschaft
    Full Title: Finasterid-unterstützte Diagnostik des Prostatakarzinoms bei Patienten mit BPH
    Medical condition: Adenoma of the prostate, elevated serum-PSA value
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-000660-74 Sponsor Protocol Number: tamssild Start Date*: 2005-03-02
    Sponsor Name:Tuomo Nieminen
    Full Title: Tamsulosiinin ja sildenafiilin sydän- ja verenkiertoelinvaikutukset BPH-potilailla
    Medical condition: Eturauhasen hyvänlaatuinen liikakasvu, BPH
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-003532-30 Sponsor Protocol Number: BCSK/05/Pro-BPH/001 Start Date*: 2006-12-29
    Sponsor Name:Berlin-Chemie AG (Menarini Group)
    Full Title: Efficacy of two formulations of Sabal serrulata; a double-blind; randomized; placebo-controlled phase III study
    Medical condition: Benign prostate hyperplasia
    Disease: Version SOC Term Classification Code Term Level
    8.1 10014840 Enlarged prostate (benign) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: LT (Completed) DE (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2018-003135-30 Sponsor Protocol Number: URO-901-3005 Start Date*: 2019-12-12
    Sponsor Name:Urovant Sciences GmbH
    Full Title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men with Overactive Bladder (OAB) Symptoms on Pharmacolog...
    Medical condition: Overactive Bladder (OAB) in men with Benign Prostatic Hyperplasia (BPH)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004857 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: LT (Completed) ES (Ongoing) HU (Completed) PT (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-003494-26 Sponsor Protocol Number: Florence-PROTEST Start Date*: 2012-10-26
    Sponsor Name:AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
    Full Title: EVALUATION OF THE EFFECT OF TESTOSTERONE REPLACEMENT THERAPY ON PROSTATIC INFLAMMATION AND LOWER URINARY TRACT SYMPTOMS IN HYPOGONADAL SUBJECTS
    Medical condition: metabolic syndrome and BPH patients who will undergo simple prostatectomy
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004872 10004447 Benign prostatic hypertrophy LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-001212-20 Sponsor Protocol Number: 905-CL-057 Start Date*: 2009-07-16
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: An open-label, long term multi-center study to assess the safety and efficacy of fixed dose combinations of solifenacin succinate (6 mg and 9 mg) with tamsulosin hydrochloride OCAS 0.4 mg, in male ...
    Medical condition: Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038604 - Reproductive system and breast disorders 10004446 Benign prostatic hyperplasia PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Completed) AT (Completed) IT (Completed) DE (Completed) FR (Completed) HU (Completed) SK (Completed) BE (Completed) CZ (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-003136-72 Sponsor Protocol Number: URO-901-3006 Start Date*: 2021-10-28
    Sponsor Name:Urovant Sciences GmbH
    Full Title: A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Men with Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperpla...
    Medical condition: Overactive Bladder (OAB) in men with Benign Prostatic Hyperplasia (BPH)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10038359 - Renal and urinary disorders 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004422-17 Sponsor Protocol Number: ANDRO-AOUC-2014-1 Start Date*: 2015-04-14
    Sponsor Name:UNIVERSITY OF FLORENCE
    Full Title: Double-blinded placebo-controlled study on men with lower urinary tract symptoms secondary to prostatic hyperplasia (LUTS-BPH) to assess changes in pressure flow study (PFS) and in molecular profil...
    Medical condition: lower urinary tract symptoms/benign prostatic hyperplasia
    Disease: Version SOC Term Classification Code Term Level
    17.1 10038359 - Renal and urinary disorders 10071289 Lower urinary tract symptoms PT
    17.1 10038604 - Reproductive system and breast disorders 10004446 Benign prostatic hyperplasia PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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