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Status unknownNCT02496845Updated Jul 15, 2015

Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

A Phase 1/2 interventional study of VL#FIA3-30 in Erectile Dysfunction, sponsored by VasoLead (2012) Ltd.. Status unknown at 1 site in Israel. Open to male participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-07-15.

Sponsored by VasoLead (2012) Ltd. · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
25 Years to 75 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Erectile Dysfunction

Browse trials for

03

In context

Erectile Dysfunction

698 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.

This study's planned enrollment of 32 is below the median of 72 across 552 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

This is the only study on the registry with VasoLead (2012) Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Group A

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

    Drug: VL#FIA3-30

  • Experimental
    Groups B, C, D

    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

  • DrugVL#FIA3-30

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

    Also known as: Transdermal application

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events as a aeasure of safety and tolerability of topical VL#FIA3-30 applied on the penis

    Time frame: 2 weeks

Secondary outcomes

  1. Increase the score level of the Erection Hardness Score (EHS) index

    Time frame: 2 weeks

  2. Increase points of the International Index of Erectile Function-Erectile Function (IIEF-EF) score

    Time frame: 2 weeks

  3. Significant increase of Flow Mediated Dilation (FMD) parameters

    Time frame: 2 weeks

  4. Increase the total ED inventory of Treatment Satisfaction (EDITS) score

    Time frame: 2 weeks

  5. Improvement of patient/Investigator satisfaction VAS score

    Time frame: 2 weeks

  6. Increase the total score of the Quality of Erection Questionnaire (QEQ)

    Time frame: 2 weeks

  7. Increase the total score of the modified Quality of Erection Questionnaire (mQEQ)

    Time frame: 2 weeks

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2015, a primary completion of Nov 2015 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2015
First posted
Jul 14, 2015
Start
Aug 2015
Primary completionEst.
Nov 2015
CompletionEst.
Jan 2016
Last update
Jul 15, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02496845
Lead sponsor
VasoLead (2012) Ltd.
Responsible party
Sponsor
First posted
Jul 14, 2015
Start date
Aug 2015
Primary completion
Nov 2015 (estimated)
Completion
Jan 2016 (estimated)
Last update
Jul 15, 2015

Study contacts

Tami Bar, Dr.
Contact
baret@isdn.net.il
+972 (0) 54 7510042
Gruenwald Ilan, Prof.
principal investigator · Rambam Health Care Campus

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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