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
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.
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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