Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

July 13, 2015 updated by: VasoLead (2012) Ltd.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Topical treatment and PK. Administration of VL#FIA3-30 (dual administration of MH30-01 & IS045-01)
Drug: VL#FIA3-30
Vasoactive dual treatment (MH30-01 & IS045-01)
Other Names:
  • Transdermal application
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
Vasoactive dual treatment (MH30-01 & IS045-01)
Other Names:
  • Transdermal application

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome 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
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Increase the score level of the Erection Hardness Score (EHS) index
Time Frame: 2 weeks
2 weeks
Increase points of the International Index of Erectile Function-Erectile Function (IIEF-EF) score
Time Frame: 2 weeks
2 weeks
Significant increase of Flow Mediated Dilation (FMD) parameters
Time Frame: 2 weeks
2 weeks
Increase the total ED inventory of Treatment Satisfaction (EDITS) score
Time Frame: 2 weeks
2 weeks
Improvement of patient/Investigator satisfaction VAS score
Time Frame: 2 weeks
2 weeks
Increase the total score of the Quality of Erection Questionnaire (QEQ)
Time Frame: 2 weeks
2 weeks
Increase the total score of the modified Quality of Erection Questionnaire (mQEQ)
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VasoLead (2012) Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gruenwald Ilan, Prof., Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VL#FIA3-30 #002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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