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Status unknownNCT05241964Updated Feb 16, 2022

Platelet-rich Plasma(PRP) Injection in ED

An interventional study of PRP in Erectile Dysfunction and PRP, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to male participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-16.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Mar 2021, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
20 Years to 70 Years
Sex
Male
01

Study summary

RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. In theory, it is possibility of curing ED.

Read the detailed description

There are many reasons of erectile dysfunction(ED). If left untreated, there is a major impact on relationships, self-esteem, and overall health. RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. Its mechanism is to promote the regeneration of blood vessels in the cavernous body of the penis, increase blood circulation, and then help erection, increase penile stiffness and improve the phenomenon of premature ejaculation. The main purpose of this study is to study the safety and effectiveness of PRP injection for the treatment of ED.

02

Conditions studied

  • Erectile Dysfunction
  • PRP

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03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's planned enrollment of 30 is below the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Male
  • Between 20 and 70 years old
  • Sexual dysfunction exists for at least 6 months
  • IIEF-5 score 8-2
  • Sign an informed consent form

Exclusion criteria

Exclusion Criteria:

  • Ever radical prostatectomy or extensive pelvic surgery
  • Radiation therapy to the pelvic area within 12 months before recruiting
  • Cancer
  • Nervous system diseases that affect erectile function
  • Have any blood disease
  • History of coronary artery disease
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    PRP

    PRP injection

    Biological: PRP

Interventions

  • BiologicalPRP

    4\~6ml autologous platelet rich plasma injection every 14±2 days for a total of 5 injections.

06

What researchers measure

Primary outcomes

  1. International Index of Erectile Function(IIEF-5)

    The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild (12-21), and no ED (22-25).

    Time frame: Change from 0 week at 4,8,12,24,48 weeks

Secondary outcomes

  1. Erection Hardness Score(EHS)

    EHS can be a helpful tool to evaluate ED - a man's inability to get or maintain an erection firm enough for sex. To select one of the following options: 0 Penis does not enlarge 1. Penis is larger, but not hard 2. Penis is hard, but not hard enough for penetration 3. Penis is hard enough for penetration, but not completely hard 4. Penis is completely hard and fully rigid

    Time frame: Change from 0 week at 4,8,12,24,48 weeks

  2. Duplex - Peak systolic velocity(PSV)

    To assess penile hemodynamics - Penile arterial blood velocity record (cm/s)

    Time frame: 0,16 weeks

  3. Duplex - Resistance index(RI)

    To assess penile hemodynamics - Penile vascular resistance Index

    Time frame: 0,16 weeks

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05241964
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Feb 16, 2022
Start date
Mar 22, 2021
Primary completion
Sep 22, 2022 (estimated)
Completion
Nov 29, 2022 (estimated)
Last update
Feb 16, 2022

Study contacts

I-Ni Chiang, MD
Contact
inichiang@gmail.com
+886919077219
I-Ni Chiang, MD
principal investigator · Taipei Veteran General hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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