Safety Profile of Secotex ® in Patients With Benign Prostatic Hyperplasia

Secotex ®: Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02245529

Enrollment

982

Registered

2014-09-19

Start date

2005-03-31

Completion date

Unknown

Last updated

2014-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia

Brief summary

The Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving patients treated with Secotex® (Tamsulosin) in real life settings. The aim of a PEM is to monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic Hyperplasia as used in general practice

Interventions

DRUGTamsulosin

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* Patients of any age with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH) and/or that, according to the Physician, their symptoms require medical treatment to improve their quality of life. The patients could be naïve to treatment or could be on treatment with other drugs but have not responded adequately to treatment. This study is non-interventional, so the decision to treat must be based on the best standard accepted clinical practice, and according to Secotex® prescribing information

Exclusion criteria

* Patients with known hypersensitivity to Tamsulosin, or any other component of the product * Patients with a history of orthostatic hypotension or severe liver failure

Design outcomes

Primary

Measure	Time frame
Number of patients with adverse events	up to 6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026