Erectile dysfunction MedDRA version: 20.0 Level: LLT Classification code 10052003 Term: Erectile dysfunction NOS System Organ Class: 100000004872
Conditions
Interventions
Trade Name: Maxon, 50 mg, film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sildenafil citrate
CAS Number: 171599-83-0
Sponsors
Adamed Pharma S.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Sex: male. 2. Patients aged 18 years and older. 3. Patients able to understand and follow the study procedures. 4. Patients who report erectile dysfunction during the clinical examination. 5. Patients who are willing to use pharmacological treatment of erectile dysfunction. 6. Patients who have had at least one visit to a cardiologist over the past two years and remain under his care due to the diagnosed disorders (additional criterion only for inclusion into the group of patients with cardiac disorders – at least 80 patients in the study). 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Lack of reading and writing skills or comprehension in Polish. 2. Severe physical or mental concomitant disease that might hamper the realization of the trial according to the protocol. 3. Legal issues (eg. incapacitation) or others that make the patient unable to fully understand the purpose of the study, description of its course and possible consequences. 4. Unreliability or lack of cooperation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess whether patients using specially designed diagnostic tool can independently make safe decision about whether it is appropriate for them to use or not use sildenafil in dose of 50 mg.; Secondary Objective: Assessment of: -coherence of a patient’s and investigator’s decision on the possibility of taking sildenafil in certain dose. -usefulness of diagnostic tool in the decision making process concerning administration of sildenafil in certain dose. -coherence of answers given by patient on questions contained in the diagnostic tool concerning renal function, liver function and blood coagulation, with the findings implied by the results of laboratory blood tests. -coherence of answer given by patient with cardiac disorders on question concerning heart function contained in the diagnostic tool, with the findings implied by results of cardiac stress test. In regards to patients who receive IMP, the objective is to determine: -whether patient used the medication; -the patient’s perception on efficacy of used medication (whether its administration allowed achieving and maintaining a penile erection sufficient for sexual performance); -whether and what adverse drug reactions occurred. ;Primary end point(s): The proportion of patients who will independently make a safe decision on the possibility of taking sildenafil in dose 50 mg.;Timepoint(s) of evaluation of this end point: Visit 1 (after the patient uses the diagnostic tool and both patient and Investigator make independent decision on patient’s possibility of taking sildenafil). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The proportion of patients whose answers given in the diagnostic tool are consistent with the conclusions from the analysis of the results of selected laboratory blood tests parameters. 2. The proportion of patients with cardiac disorders whose answers on heart function given in the diagnostic tool are consistent with the conclusions of the cardiac stress test results. 3. The proportion of patients who, coherently with the Investigator’s opinion decide that they can take sildenafil in 25 mg or 50 mg dose, among those who decide about taking it. 4. The proportion of patients who, coherently with the Investigator’s opinion decide that they cannot take sildenafil in any dose, among those who according to Investigator’s opinion cannot take it. 5. The proportion of patients whose decision to take sildenafil in 25 mg or 50 mg dose is coherent with the Investigator's opinion. 6. The proportion of patients who decide that they can take sildenafil in 25 mg or 50 mg dose, among those who according to Investigator’s opinion can take it. 7. The proportion of patients who will make a decision coherent with the decision indicated by the answers given when using the diagnostic tool. 8. For a selected group of patients with cardiac disorders (total 20 patients) who will receive the IMP, a descriptive analysis will be carried out on the following matters: -whether the patient used the medication; -what was the patient's perception on efficacy of used medication (whether its administration allowed achieving and maintaining a penile erection sufficient for sexual performance); -whether and what adverse drug reactions have occurred. ; Timepoint(s) of evaluation of this end point: End points 3-7 - Visit 1 (after the patient uses the diagnostic tool and both patient and Inve | — |
Countries
Poland
Contacts
Public ContactCoordinating Investigator
Roland Dadej
Outcome results
None listed