The Role of Platelet Rich Plasma for Erectile Dysfunction | NCT04357353

Studies
The Role of Platelet Rich Plasma for Erectile Dysfunction

NCT04357353

Sponsor

University of Nebraska

Status

Terminated

Last Update Posted

Aug 29, 2023Actual

Enrollment

13Actual

Phase

Phase 3

Conditions

Erectile Dysfunction

Interventions

Platelet rich plasma
Placebo Sham Injection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low enrollment

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

Nov 2, 2022Actual

Completion Date

Nov 2, 2022Actual

First Submitted Date

Apr 19, 2020

First Submission Date that Met QC Criteria

Apr 19, 2020

First Posted Date

Apr 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2023

Last Update Posted Date

Aug 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Eligibility: Men with erectile dysfunction. Ages 50-80. International Index of Erectile Function score of mild (17-21/25) or moderate (8-16/25).

Intervention and Evaluation:Men who consent to join the trial will be randomized to receive either a single injection PRP or saline to the penis. All patients will have blood drawn in clinic the day of injection. Those randomized to PRP arm will have their own blood prepared and separated into the PRP. This solution of their own blood will be injected back into the penis.

Follow Up: Men will be evaluated at 1 , 3, and 6 months after the injections and then asked to complete the IIEF by phone or by electronic means

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Platelet rich plasma	Biological	PRP will be used in the experimental arm.	Platelet rich plasma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Erectile Function Change	The rate of change in erectile function measured by IIEF	at 1, 3 and 6 months

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Side Effects	any side effects noted by men	at 1, 3 and 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

history of mild to moderate erectile dysfunction measured by IIEF

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Only men suffer from erectile dysfunction

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chris Deibert, MD, MPH	University of Nebraska	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unversity of Nebraska Medical Center		Omaha	Nebraska	68198	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided