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Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

VL#FIA3-30

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Rambam Health Care Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A

Groups B, C, D

Arm Description

Topical treatment and PK. Administration of VL#FIA3-30 (dual administration of MH30-01 & IS045-01)

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)

Outcomes

Primary Outcome Measures

Number of participants with adverse events as a aeasure of safety and tolerability of topical VL#FIA3-30 applied on the penis

Secondary Outcome Measures

Increase the score level of the Erection Hardness Score (EHS) index

Increase points of the International Index of Erectile Function-Erectile Function (IIEF-EF) score

Significant increase of Flow Mediated Dilation (FMD) parameters

Increase the total ED inventory of Treatment Satisfaction (EDITS) score

Improvement of patient/Investigator satisfaction VAS score

Increase the total score of the Quality of Erection Questionnaire (QEQ)

Increase the total score of the modified Quality of Erection Questionnaire (mQEQ)

Full Information

NCT ID

NCT02496845

First Posted

June 18, 2015

Last Updated

July 13, 2015

Sponsor

VasoLead (2012) Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02496845

Brief Title

Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

November 2015 (Anticipated)

Study Completion Date

January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VasoLead (2012) Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Topical treatment and PK. Administration of VL#FIA3-30 (dual administration of MH30-01 & IS045-01)

Arm Title

Groups B, C, D

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

VL#FIA3-30

Other Intervention Name(s)

Transdermal application

Intervention Description

Vasoactive dual treatment (MH30-01 & IS045-01)

Primary Outcome Measure Information:

Title

Number of participants with adverse events as a aeasure of safety and tolerability of topical VL#FIA3-30 applied on the penis

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Increase the score level of the Erection Hardness Score (EHS) index

Time Frame

2 weeks

Title

Increase points of the International Index of Erectile Function-Erectile Function (IIEF-EF) score

Time Frame

2 weeks

Title

Significant increase of Flow Mediated Dilation (FMD) parameters

Time Frame

2 weeks

Title

Increase the total ED inventory of Treatment Satisfaction (EDITS) score

Time Frame

2 weeks

Title

Improvement of patient/Investigator satisfaction VAS score

Time Frame

2 weeks

Title

Increase the total score of the Quality of Erection Questionnaire (QEQ)

Time Frame

2 weeks

Title

Increase the total score of the modified Quality of Erection Questionnaire (mQEQ)

Time Frame

2 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tami Bar, Dr.

Phone

+972 (0) 54 7510042

baret@isdn.net.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gruenwald Ilan, Prof.

Organizational Affiliation

Rambam Health Care Campus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rambam Health Care Campus

City

Haifa

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ilan Gruenwald, Prof.

Phone

+972 (0)4 7772819

i_gruenwald@rambam.health.gov.il

12. IPD Sharing Statement

Learn more about this trial

Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

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