Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cairo University | OTHER |
| Ain Shams University | OTHER |
| Aswan University | OTHER |
| Luxor university |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to evaluate whether daily dosing with tadalafil 5 mg combined with on-demand sildenafil 100 mg can improve erectile function in men with erectile dysfunction (ED) who do not respond to PDE5 inhibitor alone.
The main questions it aims to answer are:
Researchers will compare:
to determine whether the combination regimen provides superior improvement in erectile function and patient satisfaction.
Participants will:
International Index of Erectile Function (IIEF-15) questionnaire Erection Hardness Score (EHS) assessment Reporting of any adverse effects
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Daily tadalafil 5 mg and on-demand sildenafil 100 mg |
|
| Group B | Placebo Comparator | daily Placebo and on demand sildenafil 100 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil 5 mg & Sildenafil 100mg | Drug | daily dosing of Tadalafil 5 mg combined with on demand Sildenafil 100mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Index of Erectile Function-5 (IIEF-5) total score | The IIEF-5 is a validated 5-item questionnaire assessing erectile function, with total scores ranging from 5 to 25; higher scores indicate better erectile function. | from baseline to 12 weeks after starting treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Erection Hardness Score (EHS), assessed using the validated 4-point Erection Hardness Scale | The Erection Hardness Score (EHS) is a validated 4-point scale assessing penile rigidity, with higher scores indicating better erectile hardness. | from baseline to 12 weeks after starting treatment |
| Change in International Index of Erectile Function (IIEF-15) total score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed A Shokeir+2, professor of Urology | Contact | +201121102929 | ahmed.shokeir@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed A Shokeir, professor of urology | Urology & Nephrology Center, Masnoura university, Egypt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology and Nephrology Center, Mansoura University | Recruiting | Al Mansurah | Dakahlia Governorate | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| Assiut University | OTHER |
| Minia University | OTHER |
| Alexandria University | OTHER |
| Tanta University | OTHER |
| October 6 University | OTHER |
| Al-Azhar University | OTHER |
Not provided
Not provided
Not provided
Not provided
| Sildenafil 100mg & placebo | Drug | Daily Placebo combined with on demand Sildenafil 100mg |
|
The International Index of Erectile Function (IIEF-15) is a validated 15-item questionnaire assessing erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction, with total scores ranging from 5 to 75; higher scores indicate better sexual function. |
| from baseline to 12 weeks after treatment |
| Incidence and severity of adverse events graded according to CTCAE version 5.0 | Adverse events will be recorded at each follow-up visit and classified by type, severity, and relationship to the intervention. Severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | from baseline up to 12 weeks after treatment |
| Faculty of medicine, Alexandria University | Recruiting | Alexandria | Egypt |
|
| Faculty of medicine, Aswan university | Recruiting | Aswān | Egypt |
|
| Faculty of Medicine - Assiut University | Recruiting | Asyut | Egypt |
|
| Cairo University, faculty of medicine | Recruiting | Cairo | Egypt |
|
| Faculty of medicine, Ain Shams University | Recruiting | Cairo | Egypt |
|
| Faculty of medicine, Azhar University | Recruiting | Cairo | Egypt |
|
| Faculty of medicine, october 6 Univeristy | Recruiting | Cairo | Egypt |
|
| Faculty of medicine, Luxor university | Recruiting | Luxor | Egypt |
|
| faculty of medicine, Minya University | Recruiting | Minya | Egypt |
|
| Faculty of medicine, Tanta University | Recruiting | Tanta | Egypt |
|
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D011687 | Purines |
Not provided
Not provided