Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02496845
• Other study ID #: VL#FIA3-30 #002
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: June 18, 2015
• Last updated: July 13, 2015
• Start date: August 2015
• Est. completion date: January 2016

Study information

• Verified date: July 2015
• Source: VasoLead (2012) Ltd.
• Contact: Tami Bar, Dr.
• Phone: +972 (0) 54 7510042
• Email: baret[@]isdn.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthIsrael: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• VL#FIA3-30
Vasoactive dual treatment (MH30-01 & IS045-01)

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
VasoLead (2012) Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a aeasure of safety and tolerability of topical VL#FIA3-30 applied on the penis		2 weeks	Yes
Secondary	Increase the score level of the Erection Hardness Score (EHS) index		2 weeks	No
Secondary	Increase points of the International Index of Erectile Function-Erectile Function (IIEF-EF) score		2 weeks	No
Secondary	Significant increase of Flow Mediated Dilation (FMD) parameters		2 weeks	No
Secondary	Increase the total ED inventory of Treatment Satisfaction (EDITS) score		2 weeks	No
Secondary	Improvement of patient/Investigator satisfaction VAS score		2 weeks	No
Secondary	Increase the total score of the Quality of Erection Questionnaire (QEQ)		2 weeks	No
Secondary	Increase the total score of the modified Quality of Erection Questionnaire (mQEQ)		2 weeks	No