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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Change in International Index of Erectile Function-5 (IIEF-5) total score [Срок оценки: from baseline to 12 weeks after starting treatment]

Вторичные конечные точки (3)

• Change in Erection Hardness Score (EHS), assessed using the validated 4-point Erection Hardness Scale [Срок оценки: from baseline to 12 weeks after starting treatment]
• Change in International Index of Erectile Function (IIEF-15) total score [Срок оценки: from baseline to 12 weeks after treatment]
• Incidence and severity of adverse events graded according to CTCAE version 5.0 [Срок оценки: from baseline up to 12 weeks after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Египет · 11 центров

• 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
• … и ещё 3 центра

Идентификаторы

NCT: NCT07391579 · RP.25.09.1039

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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