Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia

Efficacy and Safety of Once Daily Administration Tadalafil in Patients With Benign Prostatic Hyperplasia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06466369

Enrollment

306

Registered

2024-06-20

Start date

2024-03-15

Completion date

2024-08-01

Last updated

2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPH With Other Lower Urinary Tract Symptoms

Brief summary

The aim of the present study is to evaluate the efficacy and safety of once daily administration PDE5 inhibitors, tadalafil for 3 months as anti-inflammatory, antiproliferative and relaxant effects in ED with BPH patients.

Interventions

DRUGTadalafil

tadalafil 2.5 mg, 5 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Masking description

double-blinded

Intervention model description

Parallel, double-blinded, prospective, randomized controlled study.

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* Aged ≥ 45 years and sexually active with symptomatic benign prostatic hyperplasia (no hospitalization 3 months prior to start of treatment).

Exclusion criteria

* 1\. Patients with bladder or prostate malignancy. 2. A history of lower urinary tract surgery. 3. History of catheterization. 4. Urinary retention. 5. Urinary tract infection. 6. Stone disease. 7. Any neurological disease.

Design outcomes

Primary

Measure	Time frame
Evaluation of International prostate symptom score (IPSS)/quality of life (QoL).	3 months compared to baseline
Evaluation of International index of erectile function (IIEF).	3 months compared to baseline

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026