Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

NCT ID: NCT02496845

Last Updated: 2015-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-01-31

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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

VL#FIA3-30

Intervention Type: DRUG

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

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)

Group Type: EXPERIMENTAL

VL#FIA3-30

Intervention Type: DRUG

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

Interventions

VL#FIA3-30

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

Intervention Type: DRUG

Other Intervention Names

Transdermal application

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

VasoLead (2012) Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gruenwald Ilan, Prof.

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Rambam Health Care Campus

Haifa, , Israel

Countries

Israel

Central Contacts

Tami Bar, Dr.

Role: CONTACT

baret@isdn.net.il

+972 (0) 54 7510042

Facility Contacts

Ilan Gruenwald, Prof.

Role: primary

i_gruenwald@rambam.health.gov.il

+972 (0)4 7772819

Other Identifiers

VL#FIA3-30 #002

Identifier Type: -

Identifier Source: org_study_id