Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

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

Detailed Description
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VasoLead's preparation to treat erectile dysfunction (ED), VL#FIA3-30, is composed of 2 active pharmaceutical ingredients, both act as vasodilators via different mechanisms. Both are currently used orally in the USA and Europe for the treatment of hypertension, angina pectoris and other diseases.

Official Title
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An Open Label Randomized Study to Examine the Safety and Clinical Efficacy of Local Topical Dual Active Preparation for Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: VL#FIA3-30


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Topical treatment and PK. Administration of VL#FIA3-30 (dual administration of MH30-01 & IS045-01) | Drug: VL#FIA3-30<br>* Vasoactive dual treatment (MH30-01 & IS045-01)<br>* Other names: Transdermal application;|
| Experimental: Groups B, C, D<br>Dual topical biweekly administration and intraurethral. Triple topical weekly administration. Multiple topical administration. Administration of VL#FIA3-30 (dual administration of MH30-01 & IS045-01) | Drug: VL#FIA3-30<br>* Vasoactive dual treatment (MH30-01 & IS045-01)<br>* Other names: Transdermal application;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a aeasure of safety and tolerability of topical VL#FIA3-30 applied on the penis |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase the score level of the Erection Hardness Score (EHS) index |  | 2 weeks | 
| Increase points of the International Index of Erectile Function-Erectile Function (IIEF-EF) score |  | 2 weeks | 
| Significant increase of Flow Mediated Dilation (FMD) parameters |  | 2 weeks | 
| Increase the total ED inventory of Treatment Satisfaction (EDITS) score |  | 2 weeks | 
| Improvement of patient/Investigator satisfaction VAS score |  | 2 weeks | 
| Increase the total score of the Quality of Erection Questionnaire (QEQ) |  | 2 weeks | 
| Increase the total score of the modified Quality of Erection Questionnaire (mQEQ) |  | 2 weeks |