Erectile DysfunctionPhase 3NCT07177326
Combination Therapy of Tadalafil 2.5mg Plus Sildenafil 25mg Versus Tadalafil 5 mg Monotherapy for Treatment of Erectile Dysfunction: A Randomized, Placebo-Controlled Double-Blinded Cross-Over Study
A Phase 3 study testing Tadalafil 2.5 mg, Sildenafil 25 mg and Tadalafil 5 mg in people with Erectile Dysfunction, run by Assiut University.
Trial summary
Erectile dysfunction (ED) is characterized by the persistent inability to attain or sustain an erection adequate for satisfactory sexual intercourse. As one of the most common male sexual health disorders, ED exhibits a global prevalence of moderate-to-severe cases ranging between 5% and 20% (1). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Tadalafil 2.5 mg, Sildenafil 25 mg and Tadalafil 5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Phase 3
- 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- -Men aged 18-70 years with a clinical diagnosis of erectile dysfunction (ED) for ≥3 months.
- International Index of Erectile Function (IIEF-5) score ≤21.
- Stable sexual relationship for ≥3 months.
- Willingness to adhere to the study protocol and provide informed consent.
- No prior use of PDE5 inhibitors within 4 weeks before enrollment.
Who cannot join
- -Severe cardiovascular disease (uncontrolled hypertension, recent MI/stroke).
- Hypersensitivity to tadalafil, sildenafil, or any PDE5 inhibitor.
- Severe hepatic/renal impairment (e.g., CrCl <30 mL/min, Child-Pugh C).
- Concomitant use of nitrates, strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole).
- History of priapism, penile deformities, or radical prostatectomy.
- Major psychiatric disorders affecting compliance.
About this study
Erectile dysfunction (ED) is characterized by the persistent inability to attain or sustain an erection adequate for satisfactory sexual intercourse. As one of the most common male sexual health disorders, ED exhibits a global prevalence of moderate-to-severe cases ranging between 5% and 20% (1). Although erectile dysfunction is not life-threatening, it can substantially impair both physical and psychosocial well-being, exerting a notable negative impact on the quality of life of affected individuals and their partners.
ED is a multifactorial condition associated with vascular, psychological, and, in some cases, idiopathic causes (2). Management strategies encompass lifestyle modification, pharmacotherapy particularly with phosphodiesterase type 5 (PDE5) inhibitors, vacuum erection devices, intracavernosal injections, and surgical options (1). ED frequently coexists with metabolic and cardiovascular disorders and shows a rising incidence with advancing age and the presence of cardiovascular risk factors (2). Both physiological and psychological mechanisms may underlie the condition; psychological etiologies tend to be more prevalent in younger, otherwise healthy individuals (3). The presence of preserved nocturnal erections is a key clinical indicator suggestive of a psychogenic origin of ED (4).
Read more
Phosphodiesterase-5 inhibitors (PDE5Is) represent the primary pharmacologic therapy for ED. Currently, seven PDE5Is (avanafil, lodenafil, mirodenafil, sildenafil, tadalafil, udenafil, and vardenafil) are available in varying dosages and formulations. Their efficacy has been consistently demonstrated in randomized controlled trials (5)(6).
Sildenafil exhibits a rapid onset of action, typically beginning 30 minutes after administration, with an effective duration of 4 to 6 hours and a maximum pharmacological activity lasting up to 12 hours (7). While sildenafil is effective in managing erectile dysfunction, discontinuation rates among responders range from 20% to 50% (8). In contrast, tadalafil, a selective and long-acting PDE5 inhibitor introduced in 2003, has a slightly faster onset around 20 minutes and is recommended to be taken at least 30 minutes before sexual activity. Notably, tadalafil has the longest duration of action among PDE5 inhibitors, with effects lasting up to 72 hours. Approximately 52% of patients are able to achieve successful intercourse within 30 minutes of ingestion (9). The purpose of this study is to evaluate the efficacy and safety of Tadalafil 2.5 mg plus sildenafil 25 mg as a combination therapy versus tadalafil 5 mg monotherapy for Treatment of Erectile Dysfunction
- Conditions
- Erectile Dysfunction
- Being tested
- Tadalafil 2.5 mg, Sildenafil 25 mg, Tadalafil 5 mg
- 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 2.5 mgDrug
patients recived Tadalafil 2.5 mg daily
Sildenafil 25 mgDrug
patients recived Sildenafil 25 mg daily
Tadalafil 5 mgDrug
patients recived Tadalafil 5 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | patients recived Tadalafil 2.5 mg + Sildenafil 25 mg. Receives: Drug: Tadalafil 2.5 mg; Drug: Sildenafil 25 mg |
| Group2 | Active comparator | patients recived Tadalafil 5 mg monotherapy Receives: Drug: Tadalafil 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Erectile Function (IIEF-5 Score)
Change in Erectile Function (IIEF-5 Score)
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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 Assiut 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mostafa Khedr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177326
- Sponsor's protocol ID
- Tadal+Silden VSTadal ED
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy of Tadalafil 2.5mg Plus Sildenafil 25mg Versus Tadalafil 5 mg Monotherapy for Treatment of Erectile Dysfunction: A Randomized, Placebo-Controlled Double-Blinded Cross-Over Study
- ClinicalTrials.gov ID
- NCT07177326
- Acronym / sponsor ID
- Tadal+Silden VSTadal ED
- Conditions
- Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Sep 2025 (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 characterized by the persistent inability to attain or sustain an erection adequate for satisfactory sexual intercourse. As one of the most common male sexual health disorders, ED exhibits a global prevalence of moderate-to-severe cases ranging between 5% and 20% (1). Although erectile dysfunction is not life-threatening, it can substantially impair both physical and psychosocial well-being, exerting a notable negative impact on the quality of life of affected individuals and their partners.
ED is a multifactorial condition associated with vascular, psychological, and, in some cases, idiopathic causes (2). Management strategies encompass lifestyle modification, pharmacotherapy particularly with phosphodiesterase type 5 (PDE5) inhibitors, vacuum erection devices, intracavernosal injections, and surgical options (1). ED frequently coexists with metabolic and cardiovascular disorders and shows a rising incidence with advancing age and the presence of cardiovascular risk factors (2). Both physiological and psychological mechanisms may underlie the condition; psychological etiologies tend to be more prevalent in younger, otherwise healthy individuals (3). The presence of preserved nocturnal erections is a key clinical indicator suggestive of a psychogenic origin of ED (4).
Phosphodiesterase-5 inhibitors (PDE5Is) represent the primary pharmacologic therapy for ED. Currently, seven PDE5Is (avanafil, lodenafil, mirodenafil, sildenafil, tadalafil, udenafil, and vardenafil) are available in varying dosages and formulations. Their efficacy has been consistently demonstrated in randomized controlled trials (5)(6).
Sildenafil exhibits a rapid onset of action, typically beginning 30 minutes after administration, with an effective duration of 4 to 6 hours and a maximum pharmacological activity lasting up to 12 hours (7). While sildenafil is effective in managing erectile dysfunction, discontinuation rates among responders range from 20% to 50% (8). In contrast, tadalafil, a selective and long-acting PDE5 inhibitor introduced in 2003, has a slightly faster onset around 20 minutes and is recommended to be taken at least 30 minutes before sexual activity. Notably, tadalafil has the longest duration of action among PDE5 inhibitors, with effects lasting up to 72 hours. Approximately 52% of patients are able to achieve successful intercourse within 30 minutes of ingestion (9). The purpose of this study is to evaluate the efficacy and safety of Tadalafil 2.5 mg plus sildenafil 25 mg as a combination therapy versus tadalafil 5 mg monotherapy for Treatment of Erectile Dysfunction
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 1 | Active comparator | Drug: Tadalafil 2.5 mg, Drug: Sildenafil 25 mgpatients recived Tadalafil 2.5 mg + Sildenafil 25 mg. |
| Group2 | Active comparator | Drug: Tadalafil 5 mgpatients recived Tadalafil 5 mg monotherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- -Men aged 18-70 years with a clinical diagnosis of erectile dysfunction (ED) for ≥3 months.
- International Index of Erectile Function (IIEF-5) score ≤21.
- Stable sexual relationship for ≥3 months.
- Willingness to adhere to the study protocol and provide informed consent.
- No prior use of PDE5 inhibitors within 4 weeks before enrollment.
Key exclusion criteria (6 listed)
- -Severe cardiovascular disease (uncontrolled hypertension, recent MI/stroke).
- Hypersensitivity to tadalafil, sildenafil, or any PDE5 inhibitor.
- Severe hepatic/renal impairment (e.g., CrCl <30 mL/min, Child-Pugh C).
- Concomitant use of nitrates, strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole).
- History of priapism, penile deformities, or radical prostatectomy.
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 2.5 mgpatients recived Tadalafil 2.5 mg daily | Drug | Group 1 |
| Sildenafil 25 mgpatients recived Sildenafil 25 mg daily | Drug | Group 1 |
| Tadalafil 5 mgpatients recived Tadalafil 5 mg daily | Drug | Group2 |
Primary outcome
Change in Erectile Function (IIEF-5 Score)
Time frame: 12 week
Change in Erectile Function (IIEF-5 Score)
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 24 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tadalafil 2.5 mg, Sildenafil 25 mg and Tadalafil 5 mg in people with Erectile Dysfunction, run by Assiut University.
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: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
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 Erectile Function (IIEF-5 Score) (time frame: 12 week). 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 24 Sep 2025.