Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

NCT02496845 | Unknown Phase 1 DMC

• 1 other identifier: VL#FIA3-30 #002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: VL#FIA3-30

Groups B, C, D

EXPERIMENTAL

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

Interventions

VL#FIA3-30 DRUG

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

Also known as: Transdermal application

Group A; Groups B, C, D

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• VasoLead (2012) Ltd.: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Gruenwald Ilan, Prof.

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tami Bar, Dr.

CONTACT

+972 (0) 54 7510042; baret@isdn.net.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: July 14, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

IL (1)