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
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Mansoura University
- Enrollment
- 500
- Locations
- 11
- Primary Endpoint
- Change in International Index of Erectile Function-5 (IIEF-5) total score
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sexually active male.
- •History of ED for ≥6 months.
- •Erectile function domain of IIEF-15 score <
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Group A
Daily tadalafil 5 mg and on-demand sildenafil 100 mg
Intervention: Tadalafil 5 mg & Sildenafil 100mg (Drug)
Group B
daily Placebo and on demand sildenafil 100 mg
Intervention: Sildenafil 100mg & placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in Erection Hardness Score (EHS), assessed using the validated 4-point Erection Hardness Scale(from baseline to 12 weeks after starting treatment)
- Change in International Index of Erectile Function (IIEF-15) total score(from baseline to 12 weeks after treatment)
- Incidence and severity of adverse events graded according to CTCAE version 5.0(from baseline up to 12 weeks after treatment)