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Clinical Trials/EUCTR2018-002597-41-PL
EUCTR2018-002597-41-PL
Active, not recruiting
Phase 1

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

Adamed Pharma S.A.0 sites400 target enrollmentOctober 17, 2018

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Erectile dysfunction
Sponsor
Adamed Pharma S.A.
Enrollment
400
Status
Active, not recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 17, 2018
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility 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

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.

Outcomes

Primary Outcomes

Not specified

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