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New treatment option for Erectile Dysfunction Due to Arterial Insufficiency
Official title PRP Exosomes Therapy for Erectile Dysfunction
ClinicalTrials.gov ID: NCT07124871
What this study is testing
What is PRP-derived exosomes injection?
PRP-derived exosomes injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for erectile dysfunction due to arterial insufficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- It will be a Single-arm, single-center, feasibility clinical trial with Primary Objective to investigate the treatment efficacy of PRP-derived exosomes injection in men with mild-moderate vasculogenic ED, as measured by the International Index of Erectile Function (IIEF). Also secondary objectives will be to study the adverse events and safety of the PRP-derived exosomes injection treatment in vasculogenic ED patients Study Centers The study will be carried out at Saint Lucas Hospital, Thessaloniki, Greece.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70, men only
You may be able to join if
- Consent to participate.
- Age 40-70 years.
- Sexually active in a stable, heterosexual relationship of more than three months duration.
- Presence of ED for at least 6 months.
- IIEF-ED: 17-25 at visit 2. The IIEF classifies the severity of ED into five categories stratified by score: No ED: 26-30, Mild ED: 22-25, Mild to...
You likely can't join if
- Previous major pelvic surgery or pelvic trauma that could impact EF, such as radical prostatectomy, radical cystectomy, or rectal surgery. 19
- Patients with previous transurethral resection of the prostate (TURP) surgery without sequelae of iatrogenic ED may be included.
- Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication...
- Previous history of priapism or penile fracture
- Previous radiation therapy to the pelvis.
- Abnormal morning serum testosterone level, defined as a value lower than 300 ng/dL (indicative of untreated hypogonadism) or greater than1197 ng/dL.
See the full eligibility criteria
- Consent to participate.
- Age 40-70 years.
- Sexually active in a stable, heterosexual relationship of more than three months duration.
- Presence of ED for at least 6 months.
- IIEF-ED: 17-25 at visit 2. The IIEF classifies the severity of ED into five categories stratified by score: No ED: 26-30, Mild ED: 22-25, Mild to moderate ED: 17-21, Moderate ED: 11-16 and Severe ED: 6-10.
- Patients will be PDE5i users for at least 6 months and report some/good response to PDE5i in the last month before screening (at visit 1
- Agree to suspend all ED therapy for the duration of the study.
- Agree to attempt sexual intercourse at least 4 times every 3 weeks for the duration of the study without being under the influence of alcohol or recreational drugs.
- Agree to document the outcome using IIEF questionnaire during every visit and the Sexual Encounter Profile (SEP) diary, as needed (months 1 and 3 post treatment).
- Previous major pelvic surgery or pelvic trauma that could impact EF, such as radical prostatectomy, radical cystectomy, or rectal surgery. 19
- Patients with previous transurethral resection of the prostate (TURP) surgery without sequelae of iatrogenic ED may be included.
- Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication, and grafting.
- Previous history of priapism or penile fracture
- Previous radiation therapy to the pelvis.
- Abnormal morning serum testosterone level, defined as a value lower than 300 ng/dL (indicative of untreated hypogonadism) or greater than1197 ng/dL.
- Current or previous hormone use, other than prescribed testosterone, clomiphene or thyroid medication. people with prior or current use of hormonal treatment for prostate cancer are also excluded.
- Psychogenic ED.
- Peyronie's Disease or penile curvature that negatively influences sexual activity.
- Anatomical or neurological abnormalities in the treatment area.
- Any untreated medical condition (based on medical history)
- Patients with generalized polyneuropathy or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis, or Parkinson's Disease.
- Refusal to suspend ED therapy for the duration of the study. people who are using Tadalafil as a treatment for benign prostatic hyperplasia (BPH) will also be excluded.
- Men deemed not healthy enough to participate in sexual activity.
- Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
- Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study.
- History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
- Any history of significant psychiatric diseases, 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 SSRI or psychotropic medications.
- Partners who are \< 18 years of age, who are nursing, who wish to become pregnant during the study period, and who have any gynecologic problems, sexual dysfunction, or major medical conditions that would limit...
- Patients with any hematological disorder
The study team makes the final eligibility decision.
Where it's taking place
- Thessaloniki, Greece
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thessaloniki, Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.