Clinical trial Recruiting at 5 sites Observational Ages 18 to 100 Men only

Observational study on BPH treatment in Greek men

Official title: Real World Study in Greek Patients with BPH for the Evaluation of Disease Control and QoL Under FDC Treatment with Solifenacin/tamsulosin

Run by Elpen Pharmaceutical Co. Inc. · NCT06528613 · Data updated 2026-11-12

This study is trying to see if a combination of two medications can help Greek men with moderate to severe BPH symptoms feel better when other treatments haven't worked well enough.

Quick facts

Study typeObservational
Ages18 Years to 100 Years
SexMen only
Enrollment450 (estimated)
SponsorElpen Pharmaceutical Co. Inc.
Industry-sponsored
Locations6 sites (Athens, Greece and 5 other locations)
StatusRecruiting
StartedOctober 23, 2024
Main results expectedSeptember 30, 2025
Study endsSeptember 30, 2025
Registry record updatedMarch 12, 2025
Trial IDNCT06528613 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adult males with moderate to severe BPH symptoms who are currently on monotherapy but not achieving satisfactory results.

Probably not a fit

Patients with mild symptoms of BPH or those who are not currently receiving treatment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on Greek male patients suffering from benign prostatic hyperplasia (BPH) who have moderate to severe symptoms and are not adequately responding to monotherapy. The study aims to assess disease control and quality of life under fixed-dose combination treatment with Solifenacin and Tamsulosin. It will involve multiple urology departments across Greece, collecting data on patient experiences and outcomes related to their BPH treatment. The study will help to better understand the effectiveness of this combination therapy in real-world settings.

Why it matters

Potential benefit: If successful, this study could improve treatment strategies for BPH, enhancing patient quality of life.

How similar studies have gone: While there have been studies on BPH treatments, this specific combination therapy in a real-world observational setting is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Male adult patient with moderate to severe symptoms of BPH receiving monotherapy and not responding adequately.
* Male adult patient with BPH who has fully understood the study procedures and signed an informed consent form.

Exclusion Criteria:

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Where it's running

  • Department of Urology, Venizelio General Ηospital
    Heraklion, Greece, Greece
    Recruiting
  • Department of Urology, General Hospital of Messinia
    Kalamata, Greece, Greece
    Recruiting
  • Department of Urology, General Hospital of Larissa
    Larissa, Greece, Greece
    Recruiting
  • Department of Urology, University Hospital of Rion
    Pátrai, Greece, Greece
    Recruiting
  • First Department of Urology, School of Medicine, Aristotle University of Thessaloniki
    Thessaloniki, Greece, Greece
    Recruiting
  • Second Department of Urology, Sismanoglio Hospital, Athens, Greece.
    Athens, Greece, Greece
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.