NCT06466369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

June 14, 2024

Last Update Submit

August 21, 2024

Conditions

BPH With Other Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Controlled group

NO INTERVENTION

Low-dose intervention group

EXPERIMENTAL
Drug: Tadalafil

High-dose intervention group

EXPERIMENTAL
Drug: Tadalafil

Interventions

TadalafilDRUG

tadalafil 2.5 mg, 5 mg

High-dose intervention groupLow-dose intervention group

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, Egypt

Location

MeSH Terms

Interventions

Tadalafil

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
double-blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel, double-blinded, prospective, randomized controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 20, 2024

Study Start

March 15, 2024

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

August 23, 2024

Record last verified: 2024-08

Locations

EG(1)