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Daily Tadalafil as Adjunctive Therapy Versus Monotherapy for PDE5 Inhibitor-Resistant Erectile Dysfunction

RecruitingPhase 4

Sponsor: Al-Azhar University

Conditions: Erectile Dysfunction, Tadalafil

Interventions: Tadalafil; Current on-demand PDE5 inhibitor, Tadalafil 5 mg

Countries: Egypt

This randomized trial will compare daily tadalafil 5 mg as adjunct therapy versus monotherapy in men with on-demand PDE5 inhibitor-resistant erectile dysfunction. The study will evaluate changes in erectile function, treatment satisfaction, partner satisfaction, and safety over 12 weeks.

Eligibility overview

Sex: MALE

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Cairo, Egypt