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NCT04396795 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.

A Phase 2 study, sponsored by University of Miami.

Completed
Registry status
Phase 2
Development phase
61
Enrollment target

NCT04396795: Completed Phase 2 study, sponsored by University of Miami.

NCT04396795 is a Phase 2 study that has completed, run by University of Miami. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04396795, a Phase 2 study, has completed, sponsored by University of Miami.

COMPLETED
Registry status
Phase 2
Development phase
61 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate changes in vascular parameters and International Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma (PRP) to participants with Erectile Dysfunction (ED)

Primary Outcome

Minimal clinically important difference (MCID) is measured by the number of participants who have achieved an increase in International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) based on their Erectile Dysfunction (ED) severity at baseline (an increase of 2 points from baseline for participants with mild ED and an increase of 5 points for participants with moderate ED). MCID in IIEF-EF scores are used to determine treatment efficacy of PRP compared to placebo. IIEF

Interventions

  • DRUG Autologous Platelet Rich Plasma
  • OTHER Saline solution

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2020-05-21
Est. Completion 2023-04-18
Phase Phase 2
University of Miami

721 total trials

What the finished NCT04396795 record still lists

NCT04396795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).

The record links to 0 conditions, and to 2 interventions - of which Autologous Platelet Rich Plasma is the first listed.

NCT04396795 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04396795 about?

NCT04396795 is a clinical study titled "Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.". The purpose of this study is to evaluate changes in vascular parameters and International Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma (PRP) to participants with Erectile Dysfunction (ED)

What is the current status of trial NCT04396795?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2020-05-21. Estimated completion is 2023-04-18.

What interventions are being tested in trial NCT04396795?

The interventions under investigation include: Autologous Platelet Rich Plasma (DRUG), Saline solution (OTHER).

Who is sponsoring clinical trial NCT04396795?

This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04396795's enrollment target sits among peer trials

61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04396795, the US trial registry maintained by the National Library of Medicine. NCT04396795 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.