Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

• Status: Unknown status
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

VL#FIA3-30 is a preparation intended for topical use, applied on the penis, for the treatment of ED.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VasoLead (2012) Ltd.

Criteria

Inclusion Criteria:

• Signed written informed consent.

• ED for more than six months in duration.

• IIEF-EF domain score at baseline from 11 to 19 .

• Willingness for a minimum of two sexual attempts during the short period of this study.

• At least 50% unsuccessful sexual intercourse for 4 attempts on 4 different days.

• A stable heterosexual relationship with the same partner for more than six months.

• Age 25 to 75 years old.

Exclusion Criteria:

• Neurological pathology;

• Prior radical prostatectomy;

• Any unstable medical or psychiatric condition, spinal cord injury, or penile anatomical abnormalities;

• Clinically significant chronic hematological disease;

• Cardiovascular conditions that prevent sexual activity (CHF or severe coronary artery disease);

• History of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to enrollment into the study;

• Use of anti-androgens, or oral or injectable androgens;

• Documented hypotension (BP below 100 systolic or 70 diastolic) or known orthostatic hypotension;

• Routine use of more than 2 antihypertensive medications;

• Use of oral nitrates within 3 months prior to enrollment into the study;

• Cancer within the last 3 years;

• Documented allergic reaction;

• Investigators impression for patient non-compliance;

• Hepatic or renal failure;

• History of HIV, hepatitis B, hepatitis C;

• Is an immediate family member of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site;

• Subject has taken any investigational medication within 30 days prior of entry into the study

• Employed by VasoLead (2012) Ltd.