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CompletedNCT06466369Updated Aug 23, 2024

Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia

A Phase 3 interventional study of Tadalafil in BPH With Other Lower Urinary Tract Symptoms, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by Al-Azhar University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
306
Allocation
Randomized
Ages
45 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • BPH With Other Lower Urinary Tract Symptoms
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 306 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
306 participants (actual)

Study arms

  • No intervention
    Controlled group
  • Experimental
    Low-dose intervention group

    Drug: Tadalafil

  • Experimental
    High-dose intervention group

    Drug: Tadalafil

Interventions

  • DrugTadalafil

    tadalafil 2.5 mg, 5 mg

06

What researchers measure

Primary outcomes

  1. Evaluation of International prostate symptom score (IPSS)/quality of life (QoL).

    Time frame: 3 months compared to baseline

  2. Evaluation of International index of erectile function (IIEF).

    Time frame: 3 months compared to baseline

07

Study locations

1 site
  • outpatient clinic of the urology department at AlZahraa University Hospital, Al-Azhar University, Faculty of Medicine for Girls.
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06466369
Lead sponsor
Al-Azhar University
Responsible party
ahmed salah saad abomandour (Principal Investigator, Al-Azhar University) — Principal investigator
First posted
Jun 20, 2024
Start date
Mar 15, 2024
Primary completion
Jul 1, 2024
Completion
Aug 1, 2024
Last update
Aug 23, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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