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Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

Sponsor
VasoLead (2012) Ltd. (Other)
Overall Status
Unknown status
CT.gov ID
NCT02496845
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
5
Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Randomized Study to Examine the Safety and Clinical Efficacy of Local Topical Dual Active Preparation for Erectile Dysfunction
Study Start Date :
Aug 1, 2015
Anticipated Primary Completion Date :
Nov 1, 2015
Anticipated Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Increase the score level of the Erection Hardness Score (EHS) index [2 weeks]

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

    3. Significant increase of Flow Mediated Dilation (FMD) parameters [2 weeks]

    4. Increase the total ED inventory of Treatment Satisfaction (EDITS) score [2 weeks]

    5. Improvement of patient/Investigator satisfaction VAS score [2 weeks]

    6. Increase the total score of the Quality of Erection Questionnaire (QEQ) [2 weeks]

    7. Increase the total score of the modified Quality of Erection Questionnaire (mQEQ) [2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rambam Health Care Campus Haifa Israel

    Sponsors and Collaborators

    • VasoLead (2012) Ltd.

    Investigators

    • Principal Investigator: Gruenwald Ilan, Prof., Rambam Health Care Campus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VasoLead (2012) Ltd.
    ClinicalTrials.gov Identifier:
    NCT02496845
    Other Study ID Numbers:
    • VL#FIA3-30 #002
    First Posted:
    Jul 14, 2015
    Last Update Posted:
    Jul 15, 2015
    Last Verified:
    Jul 1, 2015
    Additional relevant MeSH terms:
    Erectile Dysfunction

    Study Results

    No Results Posted as of Jul 15, 2015