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A SINGLE-CENTRE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY TO ASSESS SAFETY AND EFFICACY OF COMBINATION THERAPY WITH VARDENAFIL 10 mg AND TAMSULOSIN 0,4 mg IN THE TREATMENT OF MEN WITH PERSISTENT IRRITATIVE URINARY SYMPTOMS - FI.LU.VA

A SINGLE-CENTRE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY TO ASSESS SAFETY AND EFFICACY OF COMBINATION THERAPY WITH VARDENAFIL 10 mg AND TAMSULOSIN 0,4 mg IN THE TREATMENT OF MEN WITH PERSISTENT IRRITATIVE URINARY SYMPTOMS - FI.LU.VA

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-022138-10-IT
Enrollment
Unknown
Registered
2011-06-09
Start date
2010-07-28
Completion date
Unknown
Last updated
2014-03-10

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

Conditions

men with persistent irritative urinary symptoms MedDRA version: 13.1 Level: PT Classification code 10005034 Term: Bladder discomfort System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: LEVITRA*12CPR RIV 10MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: Vardenafil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceut

Sponsors

AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: • Age between 40 and 80 years • Men with LUTS and OAB defined by: – IPSS, flow assessment, measurement of post void residual urine – Mean urinary frequency ?8 times /24 hours.Mean number of urgency episodes, with or without urgency incontinence ?1 episode /24 hours. ? With both irritative and obstructive symptoms • Mean voided volume 5 ml/sec with a voided volume >150 ml • Evidence of a personally signed and dated informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Hypersensitivity to vardenafil or omnic • Drugs with proven or suspected incompatibility with vardenafil or omnic • Bladder failure or Neurogenic bladder • UTI / Prostatitis • LUT disease + LUT treatment • LUT surgery • Severe systemic disease • Unable to consistently and accurately complete the protocol

Design outcomes

Primary

MeasureTime frame
Main Objective: SAFETY AND EFFICACY OF VARDENAFIL 10 MG IN PATIENTS WITH IRRITATIVE URINARY SYMPTOMS;Secondary Objective: IMPROVEMENT OF UROFLOWMETRY PARAMETERS;Primary end point(s): 1. Improvement of LUTS diary items 2. Improvement of International Prostate Symptom Score (IPSS)—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026