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NCT Number: NCT07391579

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

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

Recruiting

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Key information

Conditions

Erectile Dysfunctions Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Urology and Nephrology Center, Mansoura University, Al Mansurah, Dakahlia Governorate, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tadalafil 5 mg & Sildenafil 100mg

Drug

daily dosing of Tadalafil 5 mg combined with on demand Sildenafil 100mg

Sildenafil 100mg & placebo

Drug

Daily Placebo combined with on demand Sildenafil 100mg

Primary outcomes

  1. 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

  1. 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

    The Erection Hardness Score (EHS) is a validated 4-point scale assessing penile rigidity, with higher scores indicating better erectile hardness.

  2. Change in International Index of Erectile Function (IIEF-15) total score

    Time frame: from baseline to 12 weeks after treatment

    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.

  3. Incidence and severity of adverse events graded according to CTCAE version 5.0

    Time frame: from baseline up to 12 weeks after treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed A Shokeir+2, professor of Urology

CONTACT

[email protected]

+201121102929

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Collaborators

  • Ain Shams University
  • Al-Azhar University
  • Alexandria University
  • Assiut University
  • Aswan University
  • Cairo University
  • Luxor university
  • Minia University
  • October 6 University
  • Tanta University

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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