NCT04172558

Brief Summary

There is a new emerging concept that Botulinum Toxin Type A may have a potential role in treatment of erectile dysfunction with a longer duration of action. So, the investigators opted to perform this study to compare ICI of Botulinum Toxin Type A versus Trimix for treatment of ED.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

March 10, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

3.6 years

First QC Date

November 19, 2019

Last Update Submit

July 17, 2022

Conditions

Erectile Dysfunction

Keywords

Botulimium ToxinEractile DysfunctionICI

Outcome Measures

Primary Outcomes (3)

  • International Index of Erectile Function (IIEF)

    Changes in the Erectile Function (EF) domain score of the International Index of change of Erectile Function measured by (IIEF) between treatment periods and baseline in the 2 study arms. It ranges between 0 to 25

    baseline, 2 weeks post treatment then every 3 months post treatment

  • Dopller study

    measurement of Cavernosal artery peak systolic and end diastolic velocities before and after ICI

    baseline, 2 weeks post treatment then every 3 months post treatment

  • Erection hardness score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Clinical assessment of the Erection hardness score by the investigators in both Erection hardness score

    Erection hardness score which is ranged 0 to 4

    baseline, 2 weeks post treatment then every 3 months post treatment

Secondary Outcomes (2)

  • Sexual Encounter Profile 2&3

    baseline, 2 weeks post treatment then every 3 months post treatment

  • Global Assessment Questionnaire

    baseline, 2 weeks post treatment then every 3 months post treatment

Study Arms (2)

BTX100 group

ACTIVE COMPARATOR

ICI of Botox 100 U

Biological: OnabotulinumtoxinA

Trimix group

ACTIVE COMPARATOR

ICI of Trimix

Drug: Trimix

Interventions

OnabotulinumtoxinABIOLOGICAL

a single ICI of BTX-A 100 units one day after the penile Doppler/trimix test.

Also known as: Grroup 1
BTX100 group
TrimixDRUG

on demand ICI of Trimix

Also known as: Group 2
Trimix group

Eligibility Criteria

Age40 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 40 years with ED not responding to PDE5Is, non compliant or contraindicated to PDE5Is. A "No" response on Sexual encounter profile questions (SEP 2 \& 3)

You may not qualify if:

  • psychiatric condition Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banha University Hospitals

Banhā, Kalubiaya, 13518, Egypt

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Botulinum Toxins, Type Atrimix

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Waleed El-Shaer, MD

    Banha Univesity hosptals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Waleed El-Shaer, MD

CONTACT

01015767331waleed_elshaer@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 21, 2019

Study Start

March 10, 2019

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

EG(1)