Erectile Dysfunction
Conditions
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.
Interventions
DRUGVL#FIA3-30
Vasoactive dual treatment (MH30-01 & IS045-01)
Sponsors
VasoLead (2012) Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Increase the score level of the Erection Hardness Score (EHS) index | 2 weeks |
| Increase the total score of the Quality of Erection Questionnaire (QEQ) | 2 weeks |
| Increase the total score of the modified Quality of Erection Questionnaire (mQEQ) | 2 weeks |
| Improvement of patient/Investigator satisfaction VAS score | 2 weeks |
Countries
Israel
Contacts
Primary ContactTami Bar, Dr.
Outcome results
None listed