Erectile DysfunctionPhase 2/3NCT07761806
Comparsion of Effect of PRP,PDE5 Inhibitor in Treatment of Erectile Dysfunction
A Phase 2/3 study testing Tadalafil 5mg in people with Erectile Dysfunction, run by Ain Shams University at 1 site in Egypt.
Trial summary
Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.Erectile dysfunction (ED) is one of the commonest disorders in adult males and affects 12-19% of men of reproductive age.Erectile dysfunction can be due to vasculogenic… Read more about this study
- Who is it for?
- Ages 30 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Tadalafil 5mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to 1 Oct 2024
- Phase
- Phase 2/3
- 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 30 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
- Sexually active in a stable, heterosexual relationship of more than three months duration.
- Agree to attempt sexual intercourse at least 3 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
- Agree to comply with all study related tests/procedures.
- provide written informed consent.
Who cannot join
- Previous penile surgery of any kind (except circumcision ).
- Previous history of penile fracture or priapism.
- Psychogenic ED as determined by study investigator.
- Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity).
- Patients using Intracavernosal Injection (ICI) for management of ED.
- Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
- Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
- Any history of significant psychiatric disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between The Effect of Intracavernosal Injection of Platelet-Rich Plasma as a Single Agent vs Daily Oral 5 Phosphodiesterase Inhibitor Intake as a Single Agent Vs Combination In Improving of Erectile Dysfunction
Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.Erectile dysfunction (ED) is one of the commonest disorders in adult males and affects 12-19% of men of reproductive age.Erectile dysfunction can be due to vasculogenic, neurogenic, hormonal, veno-occlusive, psychogenic and/or pharmacogenic factors.
PRP is autologous plasma that has a platelet concentration above the concentrations typically found in whole blood and is derived from the patient's own blood (autologous) through a process of centrifugation. PDE5Is inhibit the enzyme phosphodiesterase-5 (PDE-5) leading to dilatation of the penile arteries leads to a more prolonged erection.
Read the detailed description
Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.The prevalence of erectile dysfunction (ED) increases with age, from 5% in men aged 20-39 years to 70% in men aged >70 years.
PDE5Is inhibit the enzyme phosphodiesterase-5 (PDE-5) present in the smooth muscle cells of the vessels. By inhibiting this enzyme, these drugs prevent the degradation of cGMP by PDE-5. GMP can cause activation of protein kinase G, leading to relaxation of the vascular smooth muscle. Prevention of degradation of cGMP by PDE-5 leads to the accumulation of cGMP in the vascular smooth muscle, thereby leading to dilatation of the blood vessels through phosphorylation of different downstream effector molecules. Dilatation of the penile arteries leads to a more prolonged erection. In addition, PDE5Is improve endothelial function and reduce apoptosis of vascular smooth muscle cells in the corpus cavernosum.
PRP is autologous plasma that has a platelet concentration above the concentrations typically found in whole blood and is derived from the patient's own blood (autologous) through a process of centrifugation.PRP has 7 fundamental proteins: platelet derived growth factors (PDGF), transforming growth factor-β (TGF-β), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), and adhesive proteins - fibrin, fibronectin and vitronectin.
PDGF is a glycoprotein, which emerges from degranulation of platelets at the site of injection. It activates cell membrane receptors on target cell which in turn develop high energy phosphate bonds, which activates the signal proteins to initiate specific activity of target cells. These specific activities include mitogenesis, angiogenesis.
- Conditions
- Erectile Dysfunction
- Being tested
- Tadalafil 5mg
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mgDrug
Also called Platelet Rich Plasma (PRP)
To compare between Intra Cavernous Injection of Platelet Rich Plasma (PRP) as a single agent , 5 PDE inhibitor as a single agent vs combined effect of two agent to achieve an efficient therapy with less cost for the treatment of Erectile Dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| INTRACAVERNOSAL PRP | Active comparator | About 25 patients suffering from Erectile Function and underwent Intracaveronsal injection of 7-9 ml of PRP for 3 times 4weeks apart Receives: Drug: Tadalafil 5mg |
| 5 phosphodiasterase inhibitor | Active comparator | About 25 patients suffering from Erectile Function and took a daily dose of oral 5 mg tadalafil tablets Receives: Drug: Tadalafil 5mg |
| Prp and 5 phosphodiasterase inhibitor combined | Active comparator | About 25 patients suffering from Erectile Function and underwent combined of both agents which includes daily dose of oral 5mg tadalafil tablets and Intracaveronsal injection of 7-9 ml of PRP for 3 injections 4 weeks apart Receives: Drug: Tadalafil 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Erectile Dysfunction
Treatment of the patients whom suffering from Erectile Dysfunction by using Intracavernosal Injection of Platelet-Rich Plasma as a single agent and daily oral 5 Phosphodiesterase Inhibitor intake as a single agent and combination of both agents evaluated by International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start15 Jan 2024
- Primary completion25 Aug 2024
- Study completion1 Oct 2024
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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr AbdelFattah, Ain Shams University
- Investigators
- Hisham Mohamed Fathy Salama El Shawaf, Professor, Study chair, Professor of Urology, faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761806
- Sponsor's protocol ID
- PRP in Erectile dysfunction
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between The Effect of Intracavernosal Injection of Platelet-Rich Plasma as a Single Agent vs Daily Oral 5 Phosphodiesterase Inhibitor Intake as a Single Agent Vs Combination In Improving of Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT07761806
- Acronym / sponsor ID
- PRP in Erectile dysfunction
- Conditions
- Erectile Dysfunction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 25 Aug 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 12 Aug 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.
Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.Erectile dysfunction (ED) is one of the commonest disorders in adult males and affects 12-19% of men of reproductive age.Erectile dysfunction can be due to vasculogenic, neurogenic, hormonal, veno-occlusive, psychogenic and/or pharmacogenic factors.
PRP is autologous plasma that has a platelet concentration above the concentrations typically found in whole blood and is derived from the patient's own blood (autologous) through a process of centrifugation. PDE5Is inhibit the enzyme phosphodiesterase-5 (PDE-5) leading to dilatation of the penile arteries leads to a more prolonged erection.
Detailed description
Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.The prevalence of erectile dysfunction (ED) increases with age, from 5% in men aged 20-39 years to 70% in men aged >70 years.
PDE5Is inhibit the enzyme phosphodiesterase-5 (PDE-5) present in the smooth muscle cells of the vessels. By inhibiting this enzyme, these drugs prevent the degradation of cGMP by PDE-5. GMP can cause activation of protein kinase G, leading to relaxation of the vascular smooth muscle. Prevention of degradation of cGMP by PDE-5 leads to the accumulation of cGMP in the vascular smooth muscle, thereby leading to dilatation of the blood vessels through phosphorylation of different downstream effector molecules. Dilatation of the penile arteries leads to a more prolonged erection. In addition, PDE5Is improve endothelial function and reduce apoptosis of vascular smooth muscle cells in the corpus cavernosum.
PRP is autologous plasma that has a platelet concentration above the concentrations typically found in whole blood and is derived from the patient's own blood (autologous) through a process of centrifugation.PRP has 7 fundamental proteins: platelet derived growth factors (PDGF), transforming growth factor-β (TGF-β), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), and adhesive proteins - fibrin, fibronectin and vitronectin.
PDGF is a glycoprotein, which emerges from degranulation of platelets at the site of injection. It activates cell membrane receptors on target cell which in turn develop high energy phosphate bonds, which activates the signal proteins to initiate specific activity of target cells. These specific activities include mitogenesis, angiogenesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| INTRACAVERNOSAL PRP | Active comparator | Drug: Tadalafil 5mgAbout 25 patients suffering from Erectile Function and underwent Intracaveronsal injection of 7-9 ml of PRP for 3 times 4weeks apart |
| 5 phosphodiasterase inhibitor | Active comparator | Drug: Tadalafil 5mgAbout 25 patients suffering from Erectile Function and took a daily dose of oral 5 mg tadalafil tablets |
| Prp and 5 phosphodiasterase inhibitor combined | Active comparator | Drug: Tadalafil 5mgAbout 25 patients suffering from Erectile Function and underwent combined of both agents which includes daily dose of oral 5mg tadalafil tablets and Intracaveronsal injection of 7-9 ml of PRP for 3 injections 4 weeks apart |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
- Sexually active in a stable, heterosexual relationship of more than three months duration.
- Agree to attempt sexual intercourse at least 3 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
- Agree to comply with all study related tests/procedures.
- provide written informed consent.
Key exclusion criteria (8 listed)
- Previous penile surgery of any kind (except circumcision ).
- Previous history of penile fracture or priapism.
- Psychogenic ED as determined by study investigator.
- Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity).
- Patients using Intracavernosal Injection (ICI) for management of ED.
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 |
|---|---|---|
| Tadalafil 5mgAlso: Platelet Rich Plasma (PRP)To compare between Intra Cavernous Injection of Platelet Rich Plasma (PRP) as a single agent , 5 PDE inhibitor as a single agent vs combined effect of two agent to achieve an efficient therapy with less cost for the treatment of Erectile Dysfunction. | Drug | 5 phosphodiasterase inhibitor, INTRACAVERNOSAL PRP, Prp and 5 phosphodiasterase inhibitor combined |
Primary outcome
Treatment of Erectile Dysfunction
Time frame: 6 Months
Treatment of the patients whom suffering from Erectile Dysfunction by using Intracavernosal Injection of Platelet-Rich Plasma as a single agent and daily oral 5 Phosphodiesterase Inhibitor intake as a single agent and combination of both agents evaluated by International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF).
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 12 Aug 2026.
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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.
Hisham Mohamed Fathy Salama El Shawaf, Professor study chair
Professor of Urology, faculty of Medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tadalafil 5mg in people with Erectile Dysfunction, run by Ain Shams 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 5 inclusion and 8 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 12 Aug 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Treatment of Erectile Dysfunction (time frame: 6 Months). 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 12 Aug 2026.