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Clinical Trials/EUCTR2019-003073-25-PL
EUCTR2019-003073-25-PL
Active, not recruiting
Phase 1

A multi-centre clinical trial evaluating safety and patients' ability to independently use the medicinal product indicated in the treatment of erectile dysfunction

Adamed Pharma S.A.0 sites400 target enrollmentStarted: September 26, 2019Last updated:

Overview

Phase
Phase 1
Status
Active, not recruiting
Enrollment
400

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Male

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

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.

Investigators

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