Erectile DysfunctionPhase 1/2NCT02496845
Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction
A Phase 1/2 study testing VL#FIA3-30 in people with Erectile Dysfunction, run by VasoLead (2012) Ltd. at 1 site in Israel.
Trial summary
VL#FIA3-30 is a preparation intended for topical use, applied on the penis, for the treatment of ED. Read more about this study
- Who is it for?
- Ages 25 to 75 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- VL#FIA3-30
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to Jan 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rambam Health Care Campus
Haifa
Ilan Gruenwald, Prof., +972 (0)4 7772819, i_gruenwald@rambam.health.gov.il
About this study
Official title: 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.
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.
- Conditions
- Erectile Dysfunction
- Being tested
- VL#FIA3-30
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VL#FIA3-30Drug
Also called Transdermal application
Vasoactive dual treatment (MH30-01 \& IS045-01)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Topical treatment and PK. Administration of VL#FIA3-30 (dual administration of MH30-01 \& IS045-01) Receives: 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) Receives: Drug: VL#FIA3-30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a aeasure of safety and tolerability of topical VL#FIA3-30 applied on the penis
Measured: 2 weeks
Secondary outcomes (7)
Increase the score level of the Erection Hardness Score (EHS) index
Measured: 2 weeks
Increase points of the International Index of Erectile Function-Erectile Function (IIEF-EF) score
Measured: 2 weeks
Significant increase of Flow Mediated Dilation (FMD) parameters
Measured: 2 weeks
Increase the total ED inventory of Treatment Satisfaction (EDITS) score
Measured: 2 weeks
Improvement of patient/Investigator satisfaction VAS score
Measured: 2 weeks
Increase the total score of the Quality of Erection Questionnaire (QEQ)
Measured: 2 weeks
Increase the total score of the modified Quality of Erection Questionnaire (mQEQ)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VasoLead (2012) Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gruenwald Ilan, Prof., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496845
- Sponsor's protocol ID
- VL#FIA3-30 #002
- Status last verified
- Jul 2015
- First submitted
- 18 Jun 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Randomized Study to Examine the Safety and Clinical Efficacy of Local Topical Dual Active Preparation for Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT02496845
- Acronym / sponsor ID
- VL#FIA3-30 #002
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- VasoLead (2012) Ltd.University, hospital or other
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: VL#FIA3-30Topical treatment and PK. Administration of VL#FIA3-30 (dual administration of MH30-01 \& IS045-01) |
| Groups B, C, D | Experimental | Drug: VL#FIA3-30Dual topical biweekly administration and intraurethral. Triple topical weekly administration. Multiple topical administration. Administration of VL#FIA3-30 (dual administration of MH30-01 \& IS045-01) |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VL#FIA3-30Also: Transdermal applicationVasoactive dual treatment (MH30-01 \& IS045-01) | Drug | Group A, Groups B, C, D |
Primary outcome
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
7 secondary outcomes
Increase the score level of the Erection Hardness Score (EHS) index
Time frame: 2 weeks
Increase points of the International Index of Erectile Function-Erectile Function (IIEF-EF) score
Time frame: 2 weeks
Significant increase of Flow Mediated Dilation (FMD) parameters
Time frame: 2 weeks
Increase the total ED inventory of Treatment Satisfaction (EDITS) score
Time frame: 2 weeks
Improvement of patient/Investigator satisfaction VAS score
Time frame: 2 weeks
Increase the total score of the Quality of Erection Questionnaire (QEQ)
Time frame: 2 weeks
Increase the total score of the modified Quality of Erection Questionnaire (mQEQ)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gruenwald Ilan, Prof. principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VL#FIA3-30 in people with Erectile Dysfunction, run by VasoLead (2012) Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tami Bar, Dr. (+972 (0) 54 7510042, baret@isdn.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2015.