Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2024-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

NCT00970632

Benign Prostatic Hyperplasia (BPH)

COMPLETED PHASE3

A Study of Tadalafil in Benign Prostatic Hyperplasia

NCT01183650

Benign Prostatic Hyperplasia

COMPLETED PHASE1

A Study in Benign Prostatic Hyperplasia

NCT01152190

Benign Prostatic Hyperplasia

COMPLETED PHASE3

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers

NCT00848081

Benign Prostatic Hyperplasia

COMPLETED PHASE3

(Phosphodiesterase 5 Inhibitors & α-blockers): Single Versus Combined Therapy in Benign Prostatic Hyperplasia

NCT05236634

Benign Prostatic Hyperplasia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

BPH With Other Lower Urinary Tract Symptoms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

double-blinded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Controlled group

Group Type NO_INTERVENTION

No interventions assigned to this group

Low-dose intervention group

Group Type EXPERIMENTAL

Tadalafil

Intervention Type DRUG

tadalafil 2.5 mg, 5 mg

High-dose intervention group

Group Type EXPERIMENTAL

Tadalafil

Intervention Type DRUG

tadalafil 2.5 mg, 5 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tadalafil

tadalafil 2.5 mg, 5 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No