Trial | NCT02496845  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    papaverine ...

  • Study Participants

    32
VL#FIA3-30 is a preparation intended for topical use, applied on the penis, for the treatment of ED.
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.
Study Started
Aug 31
2015
Primary Completion
Nov 30
2015
Anticipated
Study Completion
Jan 31
2016
Anticipated
Last Update
Jul 15
2015
Estimate

Drug VL#FIA3-30

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

  • Other names: Transdermal application

Group A Experimental

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

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)

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.
No Results Posted