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Recruiting NCT07391579

Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients

Phase IV Interventional Erectile Dysfunctions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tadalafil 5 mg & Sildenafil 100mg, Sildenafil 100mg & placebo.
Who it may be relevant to
Registry conditions: Erectile Dysfunctions. Basic parameters: from 21 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Drug Tadalafil 5 mg & Sildenafil 100mg
    daily dosing of Tadalafil 5 mg combined with on demand Sildenafil 100mg
  • Drug Sildenafil 100mg & placebo
    Daily Placebo combined with on demand Sildenafil 100mg

Primary outcome measures

  • Change in International Index of Erectile Function-5 (IIEF-5) total score [Time frame: from baseline to 12 weeks after starting treatment]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Egypt · 11 centers
  • Urology and Nephrology Center, Mansoura University — Al Mansurah
  • Faculty of medicine, Alexandria University — Alexandria
  • Faculty of medicine, Aswan university — Aswān
  • Faculty of Medicine - Assiut University — Asyut
  • Cairo University, faculty of medicine — Cairo
  • Faculty of medicine, Ain Shams University — Cairo
  • Faculty of medicine, Azhar University — Cairo
  • Faculty of medicine, october 6 Univeristy — Cairo
  • … and 3 more centers

Identifiers

NCT: NCT07391579 · RP.25.09.1039

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗