Erectile DysfunctionsPhase 4NCT07391579
Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients
A Phase 4 study testing Tadalafil 5 mg & Sildenafil 100mg in people with Erectile Dysfunctions, run by Mansoura University at 11 sites in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Erectile Dysfunctions
- What is being tested?
- Tadalafil 5 mg & Sildenafil 100mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 11 sitesEgypt
- Study dates
- 1 Dec 2025to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sexually active male.
- History of ED for ≥6 months.
- Erectile function domain of IIEF-15 score <17.
- Documented failure to respond to PDE-5I [definition of non-responder patients are patients with ED who don't respond to maximum dose of PDE-5I on ≥4 occasions in spite of accurate timing and good sexual stimulation].
- Stable sexual relationship ≥ 6 months.
Who cannot join
- Penile anatomical deformities or Peyronie's disease.
- Pelvic surgery or radiation.
- Active malignancy or severe systemic illness.
- Previous penile surgery of any kind, such as penile prosthesis, penile lengthening, penile cancer surgery, penile plication or grafting.
- Contraindication to PDE5i (High risk cardiac patients, patients on nitrates, hypotension).
- Using other treatments for ED e.g., Intra-cavernoasl prostaglandin injection therapy.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Egypt11 sites, 11 recruiting
- Recruiting
Urology and Nephrology Center, Mansoura University
Al Mansurah, Dakahlia Governorate
Ahmed El-Assmy, Professor of Urology, +201227112513, a_assmy@yahoo.com
Yahya H Elmorsy, MSc of Urology, +201100311999, hossam.yahya@yahoo.com
- Recruiting
Faculty of medicine, Alexandria University
Alexandria
Abdulrahman Zahran, Professor of Urology, +201005455351, abdelrahmanzahran@gmail.com
- Recruiting
Faculty of medicine, Aswan university
Aswān
Amr alameldeen, +201009081997, amr_uro2009@yahoo.com
- Recruiting
Faculty of Medicine - Assiut University
Asyut
Mohammed Naguib Elgendy, +201009882171, Elgendy8686@hotmail.com
- Recruiting
Cairo University, faculty of medicine
Cairo
Galal Mohammed ElShorbagy, Professor of Urology, +201003339381, Galal.mohammed1@kasralainy.edu.eg
- Recruiting
Faculty of medicine, Ain Shams University
Cairo
Ashraf Satour, +201000396284, Ashrafsatour@med.asu.edu.eg
- Recruiting
Faculty of medicine, Azhar University
Cairo
Mohammed ELgammal, +201000319556, gemykarter2020@gmail.com
- Recruiting
Faculty of medicine, october 6 Univeristy
Cairo
Ayman Rashed, Professor of Urology, +201006023284, aymanrashed@msn.com
- Recruiting
Faculty of medicine, Luxor university
Luxor
Ahmed Altaher, Professor of Urology, +201116552455, altaher1964.aa@gmail.com
- Recruiting
faculty of medicine, Minya University
Minya
Mohammed Hussein Qasem, +201033131812, m.hussien@mu.edu.eg
- Recruiting
Faculty of medicine, Tanta University
Tanta
Maged Ragab, Professor of Urology, +201006632607, Mmregy@gmail.com
About this study
Official title: Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients: A Multicenter Randomized, Double-Blind, Placebo-Controlled Trial
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:
Read more
- Does the combination of daily tadalafil and on-demand sildenafil lead to a greater improvement in erectile function (measured by the IIEF-EF domain) compared with on-demand sildenafil alone?
- Is the combination therapy safe and well tolerated in this patient population?
Researchers will compare:
- Group A: Daily tadalafil 5 mg plus on-demand sildenafil 100 mg
- Group B: Daily placebo plus on-demand sildenafil 100 mg to determine whether the combination regimen provides superior improvement in erectile function and patient satisfaction.
Participants will:
- Undergo baseline assessment including medical history, physical examination, and laboratory tests.
- Be randomly assigned to one of the two treatment groups.
- Take the assigned medications for 12 weeks.
- Complete follow-up evaluations at 4, 8, and 12 weeks, including:
International Index of Erectile Function (IIEF-15) questionnaire Erection Hardness Score (EHS) assessment Reporting of any adverse effects
- Conditions
- Erectile Dysfunctions
- Being tested
- Tadalafil 5 mg & Sildenafil 100mg, Sildenafil 100mg & placebo
- Keywords
- Erectile Dysfunction, ED, Sildenafil, Tadalafil, PDE5i Non-Responders, Combination Therapy
- 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 5 mg & Sildenafil 100mgDrug
daily dosing of Tadalafil 5 mg combined with on demand Sildenafil 100mg
Sildenafil 100mg & placeboDrug
Daily Placebo combined with on demand Sildenafil 100mg
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Daily tadalafil 5 mg and on-demand sildenafil 100 mg Receives: Drug: Tadalafil 5 mg & Sildenafil 100mg |
| Group B | Placebo comparator | daily Placebo and on demand sildenafil 100 mg Receives: Drug: Sildenafil 100mg & placebo |
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 (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.
Measured: from baseline to 12 weeks after starting treatment
Secondary outcomes (3)
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.
Measured: from baseline to 12 weeks after starting treatment
Change in International Index of Erectile Function (IIEF-15) total score
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.
Measured: 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.
Measured: from baseline up to 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionsStudies of the same condition, open and under way.
- More trials run by Mansoura 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Ain Shams University, Aswan University, Luxor university, Assiut University, Minia University, Alexandria University, Tanta University, October 6 University, Al-Azhar University
- Responsible party
- Sponsor
- Investigators
- Ahmed A Shokeir, professor of urology, Study chair, Urology & Nephrology Center, Masnoura university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391579
- Sponsor's protocol ID
- RP.25.09.1039
- Status last verified
- Feb 2026
- First submitted
- 18 Nov 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients: A Multicenter Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07391579
- Acronym / sponsor ID
- RP.25.09.1039
- Conditions
- Erectile Dysfunctions
- Keywords
- Erectile Dysfunction, ED, Sildenafil, Tadalafil, PDE5i Non-Responders, Combination Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Cairo University, Ain Shams University, Aswan University, Luxor university, Assiut University, Minia University, Alexandria University, Tanta University, October 6 University, Al-Azhar University
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Feb 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.
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:
- Does the combination of daily tadalafil and on-demand sildenafil lead to a greater improvement in erectile function (measured by the IIEF-EF domain) compared with on-demand sildenafil alone?
- Is the combination therapy safe and well tolerated in this patient population?
Researchers will compare:
- Group A: Daily tadalafil 5 mg plus on-demand sildenafil 100 mg
- Group B: Daily placebo plus on-demand sildenafil 100 mg to determine whether the combination regimen provides superior improvement in erectile function and patient satisfaction.
Participants will:
- Undergo baseline assessment including medical history, physical examination, and laboratory tests.
- Be randomly assigned to one of the two treatment groups.
- Take the assigned medications for 12 weeks.
- Complete follow-up evaluations at 4, 8, and 12 weeks, including:
International Index of Erectile Function (IIEF-15) questionnaire Erection Hardness Score (EHS) assessment Reporting of any adverse effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Tadalafil 5 mg & Sildenafil 100mgDaily tadalafil 5 mg and on-demand sildenafil 100 mg |
| Group B | Placebo comparator | Drug: Sildenafil 100mg & placebodaily Placebo and on demand sildenafil 100 mg |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sexually active male.
- History of ED for ≥6 months.
- Erectile function domain of IIEF-15 score <17.
- Documented failure to respond to PDE-5I [definition of non-responder patients are patients with ED who don't respond to maximum dose of PDE-5I on ≥4 occasions in spite of accurate timing and good sexual stimulation].
- Stable sexual relationship ≥ 6 months.
Key exclusion criteria (6 listed)
- Penile anatomical deformities or Peyronie's disease.
- Pelvic surgery or radiation.
- Active malignancy or severe systemic illness.
- Previous penile surgery of any kind, such as penile prosthesis, penile lengthening, penile cancer surgery, penile plication or grafting.
- Contraindication to PDE5i (High risk cardiac patients, patients on nitrates, hypotension).
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 5 mg & Sildenafil 100mgdaily dosing of Tadalafil 5 mg combined with on demand Sildenafil 100mg | Drug | Group A |
| Sildenafil 100mg & placeboDaily Placebo combined with on demand Sildenafil 100mg | Drug | Group B |
Primary outcome
Change in International Index of Erectile Function-5 (IIEF-5) total score
Time frame: from baseline to 12 weeks after starting treatment
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.
3 secondary outcomes
Change in Erection Hardness Score (EHS), assessed using the validated 4-point Erection Hardness Scale
Time frame: from baseline to 12 weeks after starting treatment
Change in International Index of Erectile Function (IIEF-15) total score
Time frame: from baseline to 12 weeks after treatment
Incidence and severity of adverse events graded according to CTCAE version 5.0
Time frame: from baseline up to 12 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed A Shokeir, professor of urology study chair
Urology & Nephrology Center, Masnoura university, Egypt
11 sites 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 5 mg & Sildenafil 100mg in people with Erectile Dysfunctions, run by Mansoura University at 11 sites 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 6 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Shokeir+2, professor of Urology (+201121102929, ahmed.shokeir@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Index of Erectile Function-5 (IIEF-5) total score (time frame: from baseline to 12 weeks after starting treatment). 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 6 Feb 2026.