Daily tadalafil added to PDE5 inhibitor therapy for men with resistant erectile dysfunction

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 randomized, parallel-group Phase 4 trial compares daily tadalafil 5 mg plus the patient’s current on-demand PDE5 inhibitor to daily tadalafil 5 mg alone in men with erectile dysfunction who have not adequately responded to on-demand treatment. Eligible participants are 21 to 70 years old with at least 6 months of ED and insufficient response to PDE5 inhibitors, confirmed by IIEF-EF score <26 and related criteria. Participants are assigned 1:1 to 12 weeks of adjunct therapy or monotherapy, with outcomes including erectile function, treatment satisfaction, partner satisfaction, and safety. The trial is conducted at Al-Azhar University-affiliated urology departments in Cairo, led by Al-Azhar University with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Age: 18 to 70 years.
* Diagnosis: Erectile dysfunction for at least 6 months.
* PDE5 inhibitor resistance: History of on-demand PDE5 inhibitor use for at least 3 months with inadequate response, defined as:
* International Index of Erectile Function-Erectile Function score less than 26 despite optimal dosing.
* Self-reported inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse in at least 50% of attempts.
* Confirmed proper medication use with at least 4 to 8 attempts with adequate sexual stimulation.
* Stable relationship: Sexually active with a female partner for at least 6 months.
* Informed consent: Willing and able to provide written informed consent.

Exclusion Criteria

* Current use of nitrates.
* Unstable cardiovascular disease, including recent myocardial infarction within 6 months, unstable angina, or severe heart failure.
* Uncontrolled hypertension greater than 180 over 110 mmHg or severe hypotension less than 90 over 50 mmHg.
* Severe hepatic impairment, Child-Pugh class C, or renal impairment with estimated glomerular filtration rate less than 30 mL per minute per 1.73 m².
* Untreated hypogonadism, total testosterone less than 250 ng/dL.
* Severe penile anatomic deformity or prior penile prosthesis.
* History of priapism.
* Severe untreated depression.
* Pelvic surgery or radiation within 6 months.

Where it's running

• Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
  Cairo, Egypt Recruiting

Study contacts

• Principal investigator: Abul-fotouh Ahmed — Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
• Study coordinator: Abul-fotouh Ahmed, MD
• Email: abulfotouhahmed@yahoo.com
• Phone: +201001066756

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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.