A multi-centre clinical trial evaluating patients’ ability to independently and safely use the medicinal product indicated in the treatment of erectile dysfunctio

Phase 1

• Conditions: Erectile dysfunction; MedDRA version: 20.0 Level: LLT Classification code 10052003 Term: Erectile dysfunction NOS System Organ Class: 100000004872; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2018-002597-41-PL
• Lead Sponsor: Adamed Pharma S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-17
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 400

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified