Platelet-Rich Plasma With or Without Tadalafil for Erectile Dysfunction

NCT07602608 | Completed Phase 4

• 1 other identifier: MD 5-10-2025
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Platelet-rich plasma is being studied as a regenerative treatment option for erectile dysfunction, but it is unclear whether adding daily tadalafil gives additional benefit over platelet-rich plasma alone. This study evaluates adult men with mild to mild-moderate erectile dysfunction who had an inadequate response to previous phosphodiesterase type 5 inhibitor treatment. Participants were randomly assigned to receive either intracavernosal platelet-rich plasma injections combined with oral tadalafil 5 milligrams once daily, or intracavernosal platelet-rich plasma injections alone. The platelet-rich plasma injection protocol consisted of three intracavernosal treatment sessions spaced two weeks apart. Erectile function was assessed using the International Index of Erectile Function-5 questionnaire at baseline and during follow-up at 1, 3, and 6 months. Penile duplex Doppler ultrasound was performed at baseline and after 6 months to assess erectile blood-flow parameters. The study hypothesis is that adding daily tadalafil to intracavernosal platelet-rich plasma may produce greater improvement in patient-reported erectile function compared with platelet-rich plasma alone, while also allowing assessment of whether this improvement is accompanied by measurable changes in penile Doppler parameters. The study included 156 participants in the final analysis, with 78 participants in each treatment group.

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; Platelet-Rich Plasma; Tadalafil; Intracavernosal Injection; Penile Duplex Doppler Ultrasound; International Index of Erectile Function; Phosphodiesterase Type 5 Inhibitor Nonresponse

Outcome Measures

Primary Outcomes (1)

• Change in International Index of Erectile Function-5 Score

  Erectile function was assessed using the International Index of Erectile Function-5 questionnaire. The total score ranges from 5 to 25, with higher scores indicating better erectile function. Scores were compared over time between the platelet-rich plasma plus tadalafil group and the platelet-rich plasma alone group.

  Baseline, 1 month, 3 months, and 6 months after treatment initiation

Secondary Outcomes (3)

• Change in Penile Peak Systolic Velocity

  Baseline and 6 months after treatment initiation

• Change in Penile End-Diastolic Velocity

  Baseline and 6 months after treatment initiation

• Change in Penile Resistive Index

  Baseline and 6 months after treatment initiation

Study Arms (2)

Platelet-Rich Plasma Plus Tadalafil

EXPERIMENTAL

Participants received intracavernosal platelet-rich plasma injections combined with oral tadalafil. Tadalafil was given as 5 milligrams tablet by mouth once daily. Platelet-rich plasma was prepared from autologous whole blood using a two-step centrifugation method, activated with calcium chloride, and injected intracavernosally using a fine-gauge needle after topical local anesthesia. The injection protocol consisted of three treatment sessions spaced two weeks apart.

Drug: Tadalafil; Procedure: Intracavernosal Platelet-Rich Plasma Injection

Platelet-Rich Plasma Alone

ACTIVE COMPARATOR

Participants received intracavernosal platelet-rich plasma injections alone without adjunct oral tadalafil. Platelet-rich plasma was prepared from autologous whole blood using a two-step centrifugation method, activated with calcium chloride, and injected intracavernosally using a fine-gauge needle after topical local anesthesia. The injection protocol consisted of three treatment sessions spaced two weeks apart.

Procedure: Intracavernosal Platelet-Rich Plasma Injection

Interventions

Tadalafil DRUG

Tadalafil was administered orally as a 5 milligram tablet once daily in combination with intracavernosal platelet-rich plasma injections. It was used as adjunct pharmacologic therapy to support erectile function during the study follow-up period.

Platelet-Rich Plasma Plus Tadalafil

Intracavernosal Platelet-Rich Plasma Injection PROCEDURE

Autologous platelet-rich plasma was prepared from whole blood using a two-step centrifugation technique and activated with calcium chloride before administration. It was injected intracavernosally using a fine-gauge needle after topical local anesthesia. The treatment protocol included three intracavernosal injection sessions spaced two weeks apart.

Platelet-Rich Plasma Alone; Platelet-Rich Plasma Plus Tadalafil

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men aged 18 years or older.
• Diagnosis of mild to mild-moderate erectile dysfunction according to the International Index of Erectile Function-5.
• Inadequate response to previous phosphodiesterase type 5 inhibitor treatment.
• Eligible for intracavernosal platelet-rich plasma injection.
• Eligible for oral tadalafil treatment.
• Baseline penile duplex Doppler ultrasound assessment available.

You may not qualify if:

• Severe erectile dysfunction.
• Peyronie's disease.
• Previous major pelvic surgery.
• Previous pelvic trauma.
• Known bleeding or coagulation disorder.
• Contraindication to phosphodiesterase type 5 inhibitors, including nitrate therapy.
• Significant cardiac disease contraindicating tadalafil use.
• Total testosterone less than 300 nanograms per deciliter.
• Refusal or inability to provide written informed consent.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology

Model Details: Participants were randomly assigned in a one-to-one ratio to one of two parallel treatment arms. One arm received intracavernosal platelet-rich plasma injections combined with oral tadalafil 5 milligrams once daily, while the other arm received intracavernosal platelet-rich plasma injections alone. Participants remained in their assigned treatment group throughout the study follow-up period.

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 22, 2026
• Study Start: April 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 16, 2025
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 6 months after publication of the main study results and will remain available for 3 years.
• Access Criteria: Data will be shared with qualified researchers who submit a scientifically sound research proposal. Requests will be reviewed by the study investigators. Data will be provided only after approval of the request and, when required, completion of a data sharing agreement.

Locations

EG (1)