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New combo therapy aims to boost erections without drugs

NCT ID NCT06433596

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether combining platelet-rich plasma (PRP) injections with shock wave therapy can improve erections in men with moderate erectile dysfunction. 116 men will receive either the real treatment or a placebo over 9 weeks, then be followed for 6 months. The goal is to see if the combination is safe and effective for improving sexual function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 116 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men over 18 years of age. 2. Erectile dysfunction present for more than 3 months in more than 50% of intercourse. 3. Baseline score of the IIEF-EF questionnaire between 11 and 21. 4. Stable heterosexual relationship of at least 6 months. 5. Commitment to have at least 3 vaginal sexual relations per month after completing treatment. 6. Commitment not to use other natural, oral, or intracavernous pharmacological treatments during the treatment and up to 6 months after its completion. 7. A patient who agrees to voluntarily enter the study by signing an informed consent. Exclusion Criteria: 1. Score of 4 on the EHS scale. 2. Patients with an international normalized ratio (INR) greater than 3. 3. Patients with sickle cell anemia. 4. Patients with clinical suspicion of hypogonadism (ADAM positive). 5. Acromegaly, gigantism, Addison disease, hyperprolactinemia, androgen deficiency. 6. Active bladder, prostate, or colon cancer. 7. Radical prostatectomy or other radical pelvic surgery. 8. History of pelvic radiotherapy. 9. Spinal cord injury or other neurological disease associated with erectile dysfunction. 10. Penile anatomical dysfunction, penile implant. 11. Platelet diseases or coagulation disorders. 12. Treatment with oral anticoagulants. 13. Platelet count outside the normal range (150 to 400 × 109/L). 14. Patients with active infections or lesions of the penis or pubic area. 15. Patients with erectile dysfunction secondary to drug treatment (antiandrogen therapy, Alpha-blockers for benign prostatic hyperplasia, use of corticosteroids, antiparkinsonian drugs, antipsychotics). 16. Patients with erectile dysfunction of psychological origin. 17. Abuse of psychoactive substances (including alcohol). 18. Cognitive or physical illness that prevents you from participating in the study, self-filling out the questionnaires, or attending therapies and controls. 19. Inability to attend therapies and controls.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Boston Medical Group Spain S.L.U

    Madrid, 28046, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.