NCT04357353

Brief Summary

Purpose of Study: This randomized controlled trial investigates the role that platelet rich plasma injections into the penis may play to improve erectile function in men with erectile dysfunction.

Trial Health

57
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Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2022

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

April 19, 2020

Last Update Submit

August 25, 2023

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Erectile Function Change

    The rate of change in erectile function measured by IIEF

    at 1, 3 and 6 months

Other Outcomes (1)

  • Side Effects

    at 1, 3 and 6 months

Study Arms (2)

Placebo

SHAM COMPARATOR

All arms will have phlebotomy (blood drawn). This group will receive saline injection only.

Other: Placebo Sham Injection

Platelet rich plasma

EXPERIMENTAL

All arms will have phlebotomy (blood drawn). This group will receive PRP injection only.

Biological: Platelet rich plasma

Interventions

Platelet rich plasmaBIOLOGICAL

PRP will be used in the experimental arm.

Also known as: blood plasma
Platelet rich plasma
Placebo Sham InjectionOTHER

sham injection

Also known as: Placebo
Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly men suffer from erectile dysfunction
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • history of mild to moderate erectile dysfunction measured by IIEF

You may not qualify if:

  • history or prostate cancer treatment (prostatectomy, radiation, brachytherapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Chris Deibert, MD, MPH

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2020

First Posted

April 22, 2020

Study Start

April 1, 2021

Primary Completion

November 2, 2022

Study Completion

November 2, 2022

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)