CompletedNCT04396795Updated Jan 9, 2024Results posted

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

A Phase 2 interventional study of Autologous Platelet Rich Plasma and Saline solution in Erectile Dysfunction, sponsored by University of Miami. Completed at 1 site in United States. Open to male participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-09.

Sponsored by University of Miami · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 61
Allocation: Randomized
Ages: 30 Years to 75 Years
Sex: Male

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)

Conditions studied

Erectile Dysfunction

Browse trials for

Erectile Dysfunction 682

Keywords

In context

Erectile Dysfunction

682 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.

This study's enrollment of 61 is below the median of 72 across 541 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

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

Who can participate

Ages eligible: 30 Years to 75 Years
Sexes eligible: Male
Accepts healthy volunteers: No

Inclusion criteria

Be Male
Be 30 to 75 years of age (inclusive).
Be able to provide written informed consent.
Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
Sexually active in a stable, heterosexual relationship of more than three months duration.
IIEF-EF score 11-25 at screening (even if taking a single PDE5).
Agree to attempt sexual intercourse at least 4 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
Agree to comply with all study related tests/procedures.

Exclusion criteria

Exclusion Criteria:

Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
Previous history of priapism or penile fracture
Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).
Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
Psychogenic ED as determined by study investigator.
Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
Patients using Intra Cavernous Injection (ICI)for management of ED
Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using Selective Serotonin Reuptake Inhibitor or psychotropic medications.
Hemoglobin a1c >9%.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 61 participants (actual)

Study arms

Experimental
PRP group
Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days
Drug: Autologous Platelet Rich Plasma
Placebo comparator
Placebo group
Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days.
Other: Saline solution

Interventions

DrugAutologous Platelet Rich Plasma
Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum.
Also known as: PRP
OtherSaline solution
Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum

What researchers measure

Primary outcomes

Number of Participants Achieving MCID in IIEF-EF.
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-EF is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. This outcome is reported as the number of participants who achieve MCID in each treatment group.
Time frame: 1 month, 3 month, 6 month

Secondary outcomes

Change in IIEF-EF Scores
IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function.
Time frame: Baseline up to Month 1, Month 3, and Month 6
Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV)
Change in Peak Systolic Velocity (PSV) assessed in cm/sec via ultrasound.
Time frame: Baseline to Month 6
Number of Adverse Events
Incidence of adverse events were reported as all urological and/or reproductive system AEs and all AEs with severity grade 3 or higher. Adverse Events severity was determined using CTCAE v5 criteria.
Time frame: 24 weeks
Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6.
Number of participants who had an End Diastolic Velocity (EDV) value of greater than 0, as assessed by penile doppler ultrasound.
Time frame: Baseline and Month 6

Results

Posted Jan 9, 2024

Participant flow

Baseline

Participant flow — Baseline
Milestone	PRP Group	Placebo Group
Started	28	33
Completed	28	33
Not completed	0	0

Month 1

Participant flow — Month 1
Milestone	PRP Group	Placebo Group
Started	28	33
Completed	26	30
Not completed	2	3
Withdrew: Lost to follow-up	2	3

Month 3

Participant flow — Month 3
Milestone	PRP Group	Placebo Group
Started	26	30
Completed	25	27
Not completed	1	3
Withdrew: Lost to follow-up	1	3

Month 6

Participant flow — Month 6
Milestone	PRP Group	Placebo Group
Started	25	27
Completed	22	24
Not completed	3	3
Withdrew: Lost to follow-up	3	3

Outcome measures

PrimaryNumber of Participants Achieving MCID in IIEF-EF.

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-EF is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. This outcome is reported as the number of participants who achieve MCID in each treatment group.

Time frame:: 1 month, 3 month, 6 month
Reported as:: Count of participants · Participants

Number of Participants Achieving MCID in IIEF-EF.
Participants	PRP Group	Placebo Group
Month 1	14	15
Month 3	10	13
Month 6	12	10

SecondaryChange in IIEF-EF Scores

IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function.

Time frame:: Baseline up to Month 1, Month 3, and Month 6
Reported as:: Median · score on a scale

Change in IIEF-EF Scores
score on a scale	PRP Group	Placebo Group
Baseline to Month 1	4.5 (0 to 8.5)	2 (-0.5 to 8)
Baseline to Month 3	1 (-3 to 7.5)	2 (-1 to 6)
Baseline to Month 6	3.5 (0 to 9.5)	2 (-2.5 to 7)

SecondaryChange in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV)

Change in Peak Systolic Velocity (PSV) assessed in cm/sec via ultrasound.

Time frame:: Baseline to Month 6
Reported as:: Median · cm/sec

Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV)
cm/sec	PRP Group	Placebo Group
Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV)	0.4 (-9.6 to 15.3)	1.5 (-3.4 to 14.8)

SecondaryNumber of Adverse Events

Incidence of adverse events were reported as all urological and/or reproductive system AEs and all AEs with severity grade 3 or higher. Adverse Events severity was determined using CTCAE v5 criteria.

Time frame:: 24 weeks
Reported as:: Number · events

Number of Adverse Events
events	PRP Group	Placebo Group
Number of Adverse Events	1	1

SecondaryNumber of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6.

Number of participants who had an End Diastolic Velocity (EDV) value of greater than 0, as assessed by penile doppler ultrasound.

Time frame:: Baseline and Month 6
Reported as:: Count of participants · Participants

Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6.
Participants	PRP Group	Placebo Group
Baseline	6	11
Month 6	9	8

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
PRP Group	0/28 (0%)	0/28 (0%)	1/28 (3.6%)
Placebo Group	0/33 (0%)	0/33 (0%)	1/33 (3%)

Most frequent other events

Most frequent other events
Event	PRP Group	Placebo Group
Reproductive system and breast disorders - Other, specifyReproductive system and breast disorders	1/28	0/33
HematomaVascular disorders	0/28	1/33

Baseline characteristics

Age, Continuous
Age, Continuous(years)	PRP Group	Placebo Group	Total
Median	49 (38.5 to 55)	46 (42 to 56)	47 (41 to 56)

Sex: Female, Male
Sex: Female, Male(Participants)	PRP Group	Placebo Group	Total
Female	0	0	0
Male	28	33	61

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	PRP Group	Placebo Group	Total
Hispanic or Latino	15	21	36
Not Hispanic or Latino	13	12	25
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	PRP Group	Placebo Group	Total
American Indian or Alaska Native	0	0	0
Asian	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	4	6	10
White	23	26	49
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Study locations

1 site

University of Miami Miller School of Medicine
Miami, Florida 33136, United States

References and documents

Publications

Andia I, Maffulli N. Platelet-rich plasma for managing pain and inflammation in osteoarthritis. Nat Rev Rheumatol. 2013 Dec;9(12):721-30. doi: 10.1038/nrrheum.2013.141. Epub 2013 Oct 1. PubMed 24080861 ↗
Sampson S, Gerhardt M, Mandelbaum B. Platelet rich plasma injection grafts for musculoskeletal injuries: a review. Curr Rev Musculoskelet Med. 2008 Dec;1(3-4):165-74. doi: 10.1007/s12178-008-9032-5. PubMed 19468902 ↗
Xie X, Zhang C, Tuan RS. Biology of platelet-rich plasma and its clinical application in cartilage repair. Arthritis Res Ther. 2014 Feb 25;16(1):204. doi: 10.1186/ar4493. PubMed 25164150 ↗
Randelli P, Randelli F, Ragone V, Menon A, D'Ambrosi R, Cucchi D, Cabitza P, Banfi G. Regenerative medicine in rotator cuff injuries. Biomed Res Int. 2014;2014:129515. doi: 10.1155/2014/129515. Epub 2014 Aug 13. PubMed 25184132 ↗
Galliera E, Corsi MM, Banfi G. Platelet rich plasma therapy: inflammatory molecules involved in tissue healing. J Biol Regul Homeost Agents. 2012 Apr-Jun;26(2 Suppl 1):35S-42S. PubMed 23648197 ↗
Nurden AT, Nurden P, Sanchez M, Andia I, Anitua E. Platelets and wound healing. Front Biosci. 2008 May 1;13:3532-48. doi: 10.2741/2947. PubMed 18508453 ↗
Lin G, Shindel AW, Fandel TM, Bella AJ, Lin CS, Lue TF. Neurotrophic effects of brain-derived neurotrophic factor and vascular endothelial growth factor in major pelvic ganglia of young and aged rats. BJU Int. 2010 Jan;105(1):114-20. doi: 10.1111/j.1464-410X.2009.08647.x. Epub 2009 Jun 2. PubMed 19493269 ↗
Apel PJ, Ma J, Callahan M, Northam CN, Alton TB, Sonntag WE, Li Z. Effect of locally delivered IGF-1 on nerve regeneration during aging: an experimental study in rats. Muscle Nerve. 2010 Mar;41(3):335-41. doi: 10.1002/mus.21485. PubMed 19802878 ↗
Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003 Jul;83(3):835-70. doi: 10.1152/physrev.2003.83.3.835. PubMed 12843410 ↗
Kushida S, Kakudo N, Morimoto N, Hara T, Ogawa T, Mitsui T, Kusumoto K. Platelet and growth factor concentrations in activated platelet-rich plasma: a comparison of seven commercial separation systems. J Artif Organs. 2014 Jun;17(2):186-92. doi: 10.1007/s10047-014-0761-5. Epub 2014 Apr 20. PubMed 24748436 ↗

Study documents

Protocol and statistical analysis plan · Jan 23, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04396795
Lead sponsor: University of Miami
Responsible party: Ranjith Ramasamy, MD (Director of Male Fertility and Andrology, University of Miami, University of Miami) — Principal investigator
First posted: May 21, 2020
Start date: May 21, 2020
Primary completion: Jan 23, 2023
Completion: Apr 18, 2023
Results posted: Jan 9, 2024
Last update: Jan 9, 2024

Study contacts

Ranjith Ramasamy, MD

principal investigator · University of Miami

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Erectile Dysfunction→

Other studies from this sponsor

University of Miami

Start the discussion