Erectile DysfunctionPhase 1NCT04350125
PRP for the Treatment of Erectile Dysfunction (ED)
A Phase 1 study testing Autologous Platelet Rich Plasma in people with Erectile Dysfunction, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to determine the safety and efficacy of Platelet Rich Plasma (PRP) in the treatment of Erectile Dysfunction (ED). Read more about this study
- Who is it for?
- Ages 45 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Autologous Platelet Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2022to 23 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given his informed and signed written consent
- The patient has ED for longer than 1 year but less than 5 years.
- The subject has a stable partner for at least 3 months.
- The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- IIEF-EF, EHS, SEP 2+3, and GAQ Domain score of 17-20 Mild to moderate vascular erectile dysfunction: PSV > 25 cm/sec
Who cannot join
- The patient is participating in another study that may interfere with the results or conclusions of this study
- History of radical prostatectomy or pelvic cancer surgery
- Prior history of pelvic malignancies
- Prior pelvic radiation therapy
- Neurological disease which effects erectile function (Spinal cord injury, iatrogenic injury to the pelvic or cavernous nerves)
- Psychiatric disease which effects erectile function
Show all 11Show fewer
- The patient is taking blood thinners
- History of Diabetes Mellitus
- History of Coronary Artery Disease
- Evidence Based Criteria: Doppler Clinical Exam ( PSV < 25 cm/sec defined criteria for severe erectile dysfunction not likely to respond to approved medical therapies)
- Biochemical evidence of Hypogonadism (total Testosterone < 300 ng/dL)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Evaluating the Use of Autologous Platelet-rich Plasma (PRP) for the Treatment of Erectile Dysfunction
Researchers are trying to determine the safety and efficacy of Platelet Rich Plasma (PRP) in the treatment of Erectile Dysfunction (ED).
- Conditions
- Erectile Dysfunction
- Being tested
- Autologous Platelet Rich Plasma
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet Rich PlasmaBiological
One 4-5mL platelet rich plasma injection administered to each side of the intracavernosal space on the right and left side of the corpus cavernosum at the base of the penis, every two weeks for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma Treatment | Experimental | Male subjects diagnosed with Erectile Dysfunction (ED) will receive platelet rich plasma injections. Receives: Biological: Autologous Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events
Number of participants to experience treatment-related adverse events defined as reaction in the skin (e.g., swelling, erythema, and warmth), injection site discomfort, penile pain, change in penile appearance, novel sexual concerns and any systemic reactions seen by the investigators, or concerns expressed by patients.
Measured: 35 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start4 Mar 2022
- Primary completion23 Oct 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Subjects treated in this study will be divided into 3 cohorts of 5. After the first cohort of 5 subjects have been treated and evaluated for safety, the second cohort of 5 subjects will proceed with treatment followed by review of events for safety. If determined safe to proceed the third cohort of 5 subjects will proceed with treatment.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory A. Broderick, Mayo Clinic
- Investigators
- Gregory Broderick, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350125
- Sponsor's protocol ID
- 18-010364
- Status last verified
- Oct 2023
- First submitted
- 14 Apr 2020
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Use of Autologous Platelet-rich Plasma (PRP) for the Treatment of Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT04350125
- Acronym / sponsor ID
- 18-010364
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are trying to determine the safety and efficacy of Platelet Rich Plasma (PRP) in the treatment of Erectile Dysfunction (ED).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects treated in this study will be divided into 3 cohorts of 5. After the first cohort of 5 subjects have been treated and evaluated for safety, the second cohort of 5 subjects will proceed with treatment followed by review of events for safety. If determined safe to proceed the third cohort of 5 subjects will proceed with treatment.
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma Treatment | Experimental | Biological: Autologous Platelet Rich PlasmaMale subjects diagnosed with Erectile Dysfunction (ED) will receive platelet rich plasma injections. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must have given his informed and signed written consent
- The patient has ED for longer than 1 year but less than 5 years.
- The subject has a stable partner for at least 3 months.
- The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- IIEF-EF, EHS, SEP 2+3, and GAQ Domain score of 17-20 Mild to moderate vascular erectile dysfunction: PSV > 25 cm/sec
Key exclusion criteria (11 listed)
- The patient is participating in another study that may interfere with the results or conclusions of this study
- History of radical prostatectomy or pelvic cancer surgery
- Prior history of pelvic malignancies
- Prior pelvic radiation therapy
- Neurological disease which effects erectile function (Spinal cord injury, iatrogenic injury to the pelvic or cavernous nerves)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Platelet Rich PlasmaOne 4-5mL platelet rich plasma injection administered to each side of the intracavernosal space on the right and left side of the corpus cavernosum at the base of the penis, every two weeks for 6 weeks. | Biological | Platelet Rich Plasma Treatment |
Primary outcome
Treatment-related adverse events
Time frame: 35 weeks
Number of participants to experience treatment-related adverse events defined as reaction in the skin (e.g., swelling, erythema, and warmth), injection site discomfort, penile pain, change in penile appearance, novel sexual concerns and any systemic reactions seen by the investigators, or concerns expressed by patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Broderick, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Platelet Rich Plasma in people with Erectile Dysfunction, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related adverse events (time frame: 35 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.