Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

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

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

Study Overview

• Status: Unknown
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: VL#FIA3-30

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 Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Tami Bar, Dr.; Phone Number: +972 (0) 54 7510042; Email: baret@isdn.net.il

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus
    • Contact: Ilan Gruenwald, Prof.; Phone Number: +972 (0)4 7772819; Email: i_gruenwald@rambam.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Topical treatment and PK. Administration of VL#FIA3-30 (dual administration of MH30-01 & IS045-01)	Drug: VL#FIA3-30; Vasoactive dual treatment (MH30-01 & IS045-01); Other Names: Transdermal application
Experimental: Groups B, C, D; 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; Vasoactive dual treatment (MH30-01 & IS045-01); Other Names: Transdermal application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: VasoLead (2012) Ltd.
• Investigators: Principal Investigator: Gruenwald Ilan, Prof., Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Estimate): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 13, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: VL#FIA3-30 #002