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NCT Number: NCT06942988

Efficacy of Intracavernous Platelet-rich Plasma Injection in the Treatment of Erectile Dysfunction

Investigation of the efficacy of autologous platelet-rich plasma administration on the potency of patients with vasculogenic and/or neurogenic erectile dysfunction

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University of Health Sciences, Bakırköy Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1)40-70 years old male, sexually active heterosexual, 2) Patients with a diagnosis of mild to moderate erectile dysfunction (IIEF score between 8-21) according to the International Index of Erectile Function (IIEF) for at least 3 months, 3) Patients who cannot achieve an erection despite peroral PDE5 inhibitor and intracavernous alprostadil injection therapy

Exclusion criteria

  • Patients with psychogenic erectile dysfunction, 2) Patients with a history of priapism, penile fracture, peyronie, penile curvature 3) Patients with a history of radical prostatectomy, 4) Patients with a history of major pelvic trauma, surgery, radiotherapy, 5) Patients with a history of malignancy affecting survival, 6) Patients with severe psychiatric illness that impairs adherence to treatment, 7) Patients with any bleeding disorder or on anti-aggregants/coagulants.

Treatment and study plan

intracavernous platelet rich plasma therapy

Biological

intracavernous platelet-rich plasma therapy for erectile dysfunction

Primary outcomes

  1. IIEF

    Time frame: 6 months

    To observe the increase in the International Index of Erectile Function (IIEF) score after treatment compared to before treatment in patients.

Secondary outcomes

  1. FSFI

    Time frame: 6 months

    To observe FSFI score increases in patients' partners before and after treatment using the Female Sexual Function Inventory (FSFI).

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Collaborators

  • t-biyoteknoloji labaratuvar estetik medikal kozmetik san. ve tic. ltd. şti.

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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