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 type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | Men only |
| Enrollment | 450 (estimated) |
| Sponsor | Elpen Pharmaceutical Co. Inc. Industry-sponsored |
| Locations | 6 sites (Athens, Greece and 5 other locations) |
| Status | Recruiting |
| Started | October 23, 2024 |
| Main results expected | September 30, 2025 |
| Study ends | September 30, 2025 |
| Registry record updated | March 12, 2025 |
| Trial ID | NCT06528613 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: \-
Where it's running
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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
- Study coordinator: Polyanthi Papanastasiou
- Email: p.papanastasiou@elpen.gr
- Phone: +302111865777
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.