Safety and Clinical Efficacy of Local Topical Treatment f... | NCT02496845

Studies
Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

NCT02496845

Sponsor

VasoLead (2012) Ltd.

Status

Unknown status

Last Update Posted

Jul 15, 2015Estimated

Enrollment

32Estimated

Phase

Phase 1Phase 2

Conditions

Erectile Dysfunction

Interventions

VL#FIA3-30

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Nov 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Jun 18, 2015

First Submission Date that Met QC Criteria

Jul 9, 2015

First Posted Date

Jul 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2015

Last Update Posted Date

Jul 15, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
VL#FIA3-30	Drug	Vasoactive dual treatment (MH30-01 & IS045-01)	Group A Groups B, C, D

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological