NCT05241964

Brief 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.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

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 22, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2022

Completed
Last Updated

February 16, 2022

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

October 6, 2021

Last Update Submit

February 14, 2022

Conditions

Erectile DysfunctionPRP

Outcome Measures

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).

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

Secondary Outcomes (3)

  • Erection Hardness Score(EHS)

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

  • Duplex - Peak systolic velocity(PSV)

    0,16 weeks

  • Duplex - Resistance index(RI)

    0,16 weeks

Study Arms (1)

PRP

EXPERIMENTAL

PRP injection

Biological: PRP

Interventions

PRPBIOLOGICAL

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

PRP

Eligibility Criteria

Age20 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

  • I-Ni Chiang, MD

    Taipei Veteran General hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

I-Ni Chiang, MD

CONTACT

+886919077219inichiang@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2021

First Posted

February 16, 2022

Study Start

March 22, 2021

Primary Completion

September 22, 2022

Study Completion

November 29, 2022

Last Updated

February 16, 2022

Record last verified: 2021-09

Locations

TW(1)