NCT03033537

Brief Summary

Introduction: Erectile dysfunction is a common condition with a significant effect on quality of life. Verapamil is calcium channel blocker of the phenyl alkylamine class which relaxes the tone of the smooth muscles lining blood vessels, leading to their dilatation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

January 20, 2017

Last Update Submit

January 24, 2017

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • IIEF5

    Questionnaire

    6 months

Study Arms (2)

Verapamil

Intracavernosal injection of Verapamil

Drug: Verapamil

Phentolamine

Intracavernosal injection of Phentolamine to treat erectile dysfunction for a period of 2 wweks

Drug: Verapamil

Interventions

VerapamilDRUG

Local treatment of erectile dysfunction

Also known as: Calcium Channel Blocker
PhentolamineVerapamil

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Males complaining of erectile dysfunction

You may qualify if:

  • Married male patients suffering from erectile dysfunction and scheduled for intracavernosal injection.

You may not qualify if:

  • Responders to PDE5-inhibitors; congenital or acquired penile anomalies; uncontrolled medical conditions or known hypersensitivity to verapamil; Peyronie's disease and any known bleeding or coagulation disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

VerapamilCalcium Channel Blockers

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic ChemicalsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCalcium-Regulating Hormones and AgentsPhysiological Effects of DrugsCardiovascular AgentsTherapeutic Uses

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 27, 2017

Study Start

July 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 20, 2016

Last Updated

January 27, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share