Clinical trial NCT02496845: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Erectile Dysfunction
Lead sponsor: VasoLead (2012) Ltd.
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 32
Sex: MALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of participants with adverse events as a aeasure of safety and tolerability of topical VL#FIA3-30 applied on the penis
timeFrame: 2 weeks
Secondary outcomes:
measure: Increase the score level of the Erection Hardness Score (EHS) index
timeFrame: 2 weeks
measure: Increase points of the International Index of Erectile Function-Erectile Function (IIEF-EF) score
timeFrame: 2 weeks
measure: Significant increase of Flow Mediated Dilation (FMD) parameters
timeFrame: 2 weeks
measure: Increase the total ED inventory of Treatment Satisfaction (EDITS) score
timeFrame: 2 weeks
measure: Improvement of patient/Investigator satisfaction VAS score
timeFrame: 2 weeks
measure: Increase the total score of the Quality of Erection Questionnaire (QEQ)
timeFrame: 2 weeks
measure: Increase the total score of the modified Quality of Erection Questionnaire (mQEQ)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Gruenwald Ilan, Prof.
role: PRINCIPAL_INVESTIGATOR
References: