Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

Phase 1

• Conditions: Erectile Dysfunction
• Interventions: Drug: VL#FIA3-30

• Registration Number: NCT02496845
• Lead Sponsor: VasoLead (2012) Ltd.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-06-18
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-09
• Last Update Submitted: 2015-07-13
• Study First Posted: 2015-07-14
• Last Update Posted: 2015-07-15
• Study Start: 2015-08
• Primary Completion: 2015-11
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	VL#FIA3-30	Topical treatment and PK. Administration of VL#FIA3-30 (dual administration of MH30-01 \& IS045-01)
Groups B, C, D	VL#FIA3-30	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Increase the score level of the Erection Hardness Score (EHS) index	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
Increase points of the International Index of Erectile Function-Erectile Function (IIEF-EF) score	2 weeks
Improvement of patient/Investigator satisfaction VAS 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

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel