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OpenTrials
Completed

NCT Number: NCT06466369

Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia

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.

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Key information

Conditions

BPH With Other Lower Urinary Tract Symptoms

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

outpatient clinic of the urology department at AlZahraa University Hospital, Al-Azhar University, Faculty of Medicine for Girls.

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tadalafil

Drug

tadalafil 2.5 mg, 5 mg

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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 20, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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