Erectile Dysfunction MedDRA version: 21.1 Level: LLT Classification code 10052003 Term: Erectile dysfunction NOS System Organ Class: 100000004872
Conditions
Interventions
Trade Name: Tadalafil Polpharma 10 mg, film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TADALAFIL
CAS Number: 171596-29-5
Concentration unit: mg/g milligram(s)/gram
Con
Sponsors
Zaklady Farmaceutyczne Polpharma S.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males aged 18 years and older. 2. Giving informed written consent to participate in the study prior to commencing the procedures covered by the study protocol 3. Patients able to understand and follow study procedures. 4. Patients who report erectile dysfunction during the clinical examination. a. Erectile dysfunction may be reported by the patient as the primary complaint underlying the visit; b. Erectile dysfunction may be revealed by an Investigator during an examination. 5. Patients who are willing to use pharmacological treatment of erectile dysfunction. Subjects enrolled into the group of patients with cardiac disorders must also met the following criteria: 6. Patients who have had at least one visit to a cardiologist in the last 2 years and are under his care because of the cardiac disorders. 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 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Lack of reading and writing skills or comprehension in Polish. 2. Symptoms of active infection. 3. Severe physical or mental disease that might hamper the realization of the trial according to the protocol. 4. Absolute contraindications to perform a cardiac stress test, which the Investigator finds based on his knowledge. 5. Legal issues (e.g. incapacitation) or others that make the patient unable to fully understand the purpose of the study, description of its course and possible consequences. 6. 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 tadalafil in dose of 10 mg.;Secondary Objective: Assessment of: - coherence of a patient’s and Investigator’s decision on the possibility of taking tadalafil in 10 mg dose. - usefulness of diagnostic tool in the decision making process concerning administration of tadalafil in 10 mg dose. - coherence of answer given by patient 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 tadalafil in dose 10 mg. The safe decision was defined as the decision consistent with the Investigator's decision or the decision not to take the drug in the tested dose, although in the Investigator's opinion the patient may take the drug. ;Timepoint(s) of evaluation of this end point: Visit 1 After the patient uses the diagnostic tool and both patients and Investigator make independent decision on patient's ability of taking tadalafil. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) The proportion of patients whose decision to take tadalafil in 10 mg dose is coherent with the Investigator's opinion. b) The proportion of patients who decide that they can take tadalafil in 10 mg dose, among those who according to Investigator’s opinion can take it. c) The proportion of patients who, coherently with the Investigator’s opinion decide that they can take tadalafil in 10 mg dose, among those who decide about taking it. d) The proportion of patients who, coherently with the Investigator’s opinion decide that they cannot take tadalafil in any dose, among those who according to Investigator’s opinion cannot take it. e) The proportion of patients who will make a decision coherent with the decision indicated by the answers given when using the diagnostic tool. f) The proportion of patients whose answers on heart function given in the diagnostic tool are consistent with the conclusions of the cardiac stress test results. g) 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: Endpoints a)-f) - Visit 1 and obtaining cardiac stress test results Endpoint g) - Visit 2 | — |
Countries
Poland
Contacts
Public ContactAgata Lazarowicz
Clinscience Sp. z o.o., biuro Bydgoszcz
Outcome results
None listed