Erectile DysfunctionPhase 4NCT07602608
Platelet-Rich Plasma With or Without Tadalafil for Erectile Dysfunction
A Phase 4 study testing Tadalafil and Intracavernosal Platelet-Rich Plasma Injection in people with Erectile Dysfunction, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Tadalafil and Intracavernosal Platelet-Rich Plasma Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2025to 16 Dec 2025
- Phase
- Phase 4
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Significant cardiac disease contraindicating tadalafil use.
- Total testosterone less than 300 nanograms per deciliter.
- Refusal or inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intracavernosal Injection of Platelet-Rich Plasma Alone Versus Combined With Oral Tadalafil in The Management of Erectile Dysfunction; A Prospective Randomized Study
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
- Being tested
- Tadalafil, Intracavernosal Platelet-Rich Plasma Injection
- Keywords
- Erectile Dysfunction, Platelet-Rich Plasma, Tadalafil, Intracavernosal Injection, Penile Duplex Doppler Ultrasound, International Index of Erectile Function, Phosphodiesterase Type 5 Inhibitor Nonresponse
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TadalafilDrug
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.
Intracavernosal Platelet-Rich Plasma InjectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Intracavernosal Platelet-Rich Plasma Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months, and 6 months after treatment initiation
Secondary outcomes (3)
Change in Penile Peak Systolic Velocity
Peak systolic velocity was measured by penile duplex Doppler ultrasound after pharmacologic stimulation. It was used to assess arterial penile blood flow. Higher values indicate better arterial inflow.
Measured: Baseline and 6 months after treatment initiation
Change in Penile End-Diastolic Velocity
End-diastolic velocity was measured by penile duplex Doppler ultrasound after pharmacologic stimulation. It was used to assess venous outflow status during erection.
Measured: Baseline and 6 months after treatment initiation
Change in Penile Resistive Index
Resistive index was calculated from penile duplex Doppler ultrasound parameters after pharmacologic stimulation. It was used as an additional measure of penile vascular resistance and erectile hemodynamics.
Measured: Baseline and 6 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 Apr 2025
- Primary completion15 Dec 2025
- Study completion16 Dec 2025
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mahmoud Ahmed M. Ghanim, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602608
- Sponsor's protocol ID
- MD 5-10-2025
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data supporting the main study results may be shared upon reasonable request. Shared data may include baseline demographic and clinical characteristics, treatment allocation, International Index of Erectile Function-5 scores, and penile duplex Doppler ultrasound parameters. No directly identifying participant information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intracavernosal Injection of Platelet-Rich Plasma Alone Versus Combined With Oral Tadalafil in The Management of Erectile Dysfunction; A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07602608
- Acronym / sponsor ID
- MD 5-10-2025
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 22 May 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Plasma Plus Tadalafil | Experimental | Drug: Tadalafil, Procedure: Intracavernosal Platelet-Rich Plasma InjectionParticipants 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. |
| Platelet-Rich Plasma Alone | Active comparator | Procedure: Intracavernosal Platelet-Rich Plasma InjectionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- Severe erectile dysfunction.
- Peyronie's disease.
- Previous major pelvic surgery.
- Previous pelvic trauma.
- Known bleeding or coagulation disorder.
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 |
|---|---|---|
| TadalafilTadalafil 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. | Drug | Platelet-Rich Plasma Plus Tadalafil |
| Intracavernosal Platelet-Rich Plasma InjectionAutologous 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. | Procedure or surgery | Platelet-Rich Plasma Alone, Platelet-Rich Plasma Plus Tadalafil |
Primary outcome
Change in International Index of Erectile Function-5 Score
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment initiation
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.
3 secondary outcomes
Change in Penile Peak Systolic Velocity
Time frame: Baseline and 6 months after treatment initiation
Change in Penile End-Diastolic Velocity
Time frame: Baseline and 6 months after treatment initiation
Change in Penile Resistive Index
Time frame: Baseline and 6 months after treatment initiation
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 22 May 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data supporting the main study results may be shared upon reasonable request. Shared data may include baseline demographic and clinical characteristics, treatment allocation, International Index of Erectile Function-5 scores, and penile duplex Doppler ultrasound parameters. No directly identifying participant information will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tadalafil and Intracavernosal Platelet-Rich Plasma Injection in people with Erectile Dysfunction, run by Benha University at 1 site in Egypt.
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 6 inclusion and 9 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 22 May 2026. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in International Index of Erectile Function-5 Score (time frame: Baseline, 1 month, 3 months, and 6 months after treatment initiation). 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 22 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.