A Study to Track the Safety of Vesomni in Men in South Korea Treated in Routine Clinical Practice for the Urinary Symptoms of Benign Prostatic Hyperplasia (Enlarged Prostate)

Sponsor
Astellas Pharma Korea, Inc.
Study ID
NCT07619105
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vesomni — DRUG
    Oral administration

Study Details

Benign prostatic hyperplasia (BPH), also known as an enlarged prostate, happens more often in men as they age. This condition causes a sudden need to pass urine, which is hard to control. Men with an enlarged prostate may need to pass urine many times during the day and night which can affect their wellbeing. There are treatments available, like tamsulosin but they don't work well in some men and can cause further health problems. Vesomni is approved in South Korea to treat urinary symptoms in men with an enlarged prostate, when treatment with tamsulosin doesn't work well enough. This study will track the safety of Vesomni given to men in South Korea who have moderate to severe symptoms from an enlarged prostate, who have previously been treated with tamsulosin and found it didn't work well. The safety of Vesomni is tracked by mainly collecting information from their medical records. The sponsor will ask for extra information to be collected, and if any health problems were caused by Vesomni. In this study, researchers want to learn about the safety of Vesomni and how well it controls symptoms in men with an enlarged prostate. The men's own doctor decides on treatment, as part of routine clinical practice, not the sponsor (Astellas). This study is about collecting information only. Most information about the safety and control of symptoms will be collected from medical records. The sponsor will also ask for extra information to be collected. All information will be collected for up to 24 weeks after the men start treatment with Vesomni.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Nov 30, 2030
Completion
Nov 30, 2030

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Vesomni
    Participants who are not adequately responding to treatment with tamsulosin monotherapy who receive Vesomni modified release tablet 6 mg/0.4 mg in routine clinical practice according to the drug label approved at the time of marketing authorization.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) or Adverse Drug Reactions (ADR) [ Time Frame: Up to 24 Weeks ]

Central Contacts

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