Daily tadalafil plus as-needed sildenafil for men whose ED did not respond to PDE5 inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4, randomized interventional study enrolls men with at least six months of erectile dysfunction who failed to respond to maximum-dose PDE5 inhibitors. Participants are randomly assigned to daily tadalafil 5 mg plus on-demand sildenafil 100 mg or daily placebo plus on-demand sildenafil 100 mg, with baseline exams and lab testing before treatment. The main efficacy outcome is change in erectile function measured by the IIEF-EF domain, and safety/tolerability are monitored throughout. The trial is conducted at multiple university urology centers in Egypt.

Why it matters

Who can join: the full rules

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.

Where it's running

• Urology and Nephrology Center, Mansoura University
  Al Mansurah, Dakahlia Governorate, Egypt Recruiting
• Faculty of medicine, Alexandria University
  Alexandria, Egypt Recruiting
• Faculty of medicine, Aswan university
  Aswān, Egypt Recruiting
• Faculty of Medicine - Assiut University
  Asyut, Egypt Recruiting
• Cairo University, faculty of medicine
  Cairo, Egypt Recruiting
• Faculty of medicine, Ain Shams University
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Ahmed A Shokeir+2, professor of Urology
• Email: ahmed.shokeir@hotmail.com
• Phone: +201121102929

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intraurethral Alprostadil Paste for Erectile Dysfunction: Dose-Escalation Study

  A 12-week, dose-escalation study tests a new alprostadil paste applied inside the urethra to see if it improves erections in men with ED who have not benefited from PDE5 inhibitors.

  Recruiting Phase 2 University of British Columbia · Vancouver, British Columbia · NCT07601646

• Traditional medicine patterns in men with erectile dysfunction

  This project will see which traditional medicine syndrome patterns are most common in men with erectile dysfunction and how those patterns relate to age, health conditions, mood, and habits like smoking and drinking.

  Recruiting University of Medicine and Pharmacy at Ho Chi Minh City · Ho Chi Minh City · NCT07487181

• Tyrosine kinase inhibitors and erectile dysfunction in men with chronic myeloid leukemia

  This will see if taking tyrosine kinase inhibitors for chronic myeloid leukemia is linked to erectile dysfunction in adult men.

  Recruiting Azienda USL Reggio Emilia - IRCCS · Reggio Emilia, RE · NCT07061145

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.