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Clinical trials for Bladder outlet obstruction

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   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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    14 result(s) found for: Bladder outlet obstruction. Displaying page 1 of 1.
    EudraCT Number: 2007-001268-57 Sponsor Protocol Number: 905-CL-058 Start Date*: 2007-09-12
    Sponsor Name:Astellas Pharma US, Inc.
    Full Title: A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of Solifenacin Succinate with 0.4 mg Tamsulosin Hydrochlo...
    Medical condition: Storage and Voiding Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027561 Micturition disorder LLT
    9.1 10005053 Bladder neck obstruction LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: CZ (Completed) BE (Completed) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-002055-32 Sponsor Protocol Number: PSD506-OAB-004 Start Date*: 2006-10-09
    Sponsor Name:Plethora Solutions Limited
    Full Title: A double-blind, placebo controlled, pilot study to assess the safety and preliminary efficacy of PSD506 in treatment-naïve or previously treated (washed out) patients with benign prostatic obstruct...
    Medical condition: This study aims to assess the safety of PSD506 in men with benign prostatic enlargement (BPE) / benign prostatic obstruction (BPO) and lower urinary tract symptoms (LUTS) and an IPSS of 8-19, in li...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10055026 Prostatic obstruction LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended) IE (Completed) GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-004380-58 Sponsor Protocol Number: A3711045 Start Date*: 2007-03-15
    Sponsor Name:Pfizer Limited
    Full Title: A MULTI-CENTER, RANDOMIZED, CROSS-OVER, DOUBLE-BLIND, THIRD PARTY OPEN, PLACEBO CONTROLLED, PILOT STUDY TO ASSESS THE URODYNAMIC EFFECTS OF MODIFIED RELEASE UK-369,003 IN MEN WITH LOWER URINARY TRA...
    Medical condition: Lower Urinary Tract Symptoms
    Disease: Version SOC Term Classification Code Term Level
    8.1 10024981 Lower urinary tract infection LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Completed) CZ (Completed) LV (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002277-38 Sponsor Protocol Number: KMD3213ITCL0477 Start Date*: 2015-07-30
    Sponsor Name:RECORDATI S.P.A.
    Full Title: Urodynamic evaluation by pressure flow urodynamic study of the new α1A-adrenoceptor antagonist silodosin 8 mg qd in patients with benign prostatic obstruction. Explorative, single-arm, phase IV cli...
    Medical condition: Benign prostatic hyperplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038604 - Reproductive system and breast disorders 10004446 Benign prostatic hyperplasia PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (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: 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: 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: 2007-004321-15 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: 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: 2009-016800-22 Sponsor Protocol Number: I1A-MC-BPAE Start Date*: 2010-05-14
    Sponsor Name:Eli Lilly and Company Limited
    Full Title: A Phase 2 Clinical Study to Evaluate Daily Oral Doses of LY500307 for 24 weeks in Men with Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (B...
    Medical condition: Benign prostatic hyperplasia
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038604 - Reproductive system and breast disorders 10004446 Benign prostatic hyperplasia PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) FR (Completed) IT (Prematurely Ended) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-001958-27 Sponsor Protocol Number: H6D-MC-LVHG Start Date*: 2006-07-13
    Sponsor Name:Lilly ICOS LLC
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men ...
    Medical condition: Primary treatment of the signs and symptoms of benign prostatic hyperplasia in men (also referred to as BPH-LUTS [lower urinary tract symptoms]). BPH-LUTS include urinary frequency, urgency, interm...
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) DE (Completed) ES (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-005665-11 Sponsor Protocol Number: KMD3213-IT-CL 0215 Start Date*: 2006-03-23
    Sponsor Name:Recordati S.p.A
    Full Title: Evaluation Of The Efficacy And Safety Of Silodosin Vs. Tamsulosin And Placebo In The Treatment Of The Signs And Symptoms Of Benign Prostatic Hyperplasia. Multicentre, Randomised, Double-Blind, Cont...
    Medical condition: Benign prostatic hyperplasia (BPH) is a non malignant enlargement of the prostate due to cellular hyperplasia of both glandular and stromal elements. As the prostate increases in size it may exert ...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10004446 LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FI (Completed) GB (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2008-004337-25 Sponsor Protocol Number: H6D-MC-LVHR Start Date*: 2009-01-19
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment o...
    Medical condition: Benign prostatic hyperplasia and erectile dysfunction.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061461 LLT
    9.1 10004446 LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Completed) PT (Completed) DE (Completed) FR (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2011-000045-20 Sponsor Protocol Number: KMD 3213 IT-CL 0376 Start Date*: 2011-06-17
    Sponsor Name:RECORDATI S.p.A
    Full Title: Effectiveness and safety of silodosin in the treatment of LUTS in patients with benign prostatic hyperplasia: a European phase IV clinical study (the Silodosin in Real-life Evaluation study)
    Medical condition: Benign prostatic hyperplasia.
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038604 - Reproductive system and breast disorders 10004446 Benign prostatic hyperplasia PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) DE (Completed) IT (Completed) PT (Completed) HU (Completed) IE (Completed) ES (Completed) RO (Completed)
    Trial results: View results
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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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