Clinical trial evaluating patients' ability to make an independent and safe decision regarding the use of the medicinal product indicated in the treatment of erectile dysfunction.

Phase 1

• Conditions: Erectile Dysfunction; MedDRA version: 21.1Level: LLTClassification code 10052003Term: Erectile dysfunction NOSSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2020-002731-30-PL
• Lead Sponsor: Zaklady Farmaceutyczne Polpharma S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-16
• Last Update Posted: 3 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 400

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

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.

Study & Design

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