NCT04577040

Unknown

Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin...

Menoufia University Source

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Other study identifiers

Sponsor study identifier

10-2020urol

Study Type

observational

Estimated enrollment

400

Locations

0 countries

Sites

N/A

Timeline

Study Start

October 1, 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

October 1, 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

October 1, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

To study Safety and efficacy of Tadalafil vs. Tadalafil with Sildosin in the management of moderately and severely symptomatic patients of prostatic hyperplasia

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 400 participants
Study completion date: October 1, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 30, 2020
Actual (reported)
Study Start
October 1, 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
First Posted
October 6, 2020
Actual (reported)
Primary Completion
October 1, 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: October 6, 2020
Status Verified: September 2020
Last Update Submitted: October 5, 2020

Conditions

Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

Symptom relief
Decreased AUA score
2 weeks

Study Arms (4)

1

Tadalafil in moderate puts

Drug: Tadalafil 5mg

2

Tadalafil in severe puts

Drug: Tadalafil 5mg

3

Tadalafil with sildosin in moderate luts

Drug: Tadalafil 5mg

4

Tadalafil with sildosin in severe luts

Drug: Tadalafil 5mg

Interventions

Tadalafil 5mgDrug

Drugs

Also known as: Sildosin

1234

Eligibility Criteria

Age45 Years - 99 Years

Sexmale(Gender-based eligibility)

Gender Eligibility DetailsBeing in prostate patients

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Middle and old aged males

You may qualify if:

Patients to be included in the study will be either:

Sponsors & Collaborators

Menoufia University
Otherlead

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: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Menoufia governorate

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 6, 2020

Study Start

October 1, 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

October 1, 2021

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o Tadalafil for Prevention of Docetaxel-Induced Peripheral Neuropathy in Prostate Cancer

Phase 2Completed

NCT05195775

Tadalafil as Adjuvant Therapy for DMD

Phase 2/3Completed

NCT04164355

Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg

Completed

NCT00334477

Efficacy and Safety of Tadalafil in Hemodialysis Patients

Phase 2Unknown

NCT05709574

Tadalafil Effect + Chemotherapy in Resectable Gastric/GEJ Cancer

Phase 2Active Not Recruiting

diagnosis of BPH based on abdominal ultrasound or digital rectal examination.

Moderate IPSS Score between 8 : 19.

severe IPSS Score between 20 : 35.

post void volume \> 100 c.

prostate size 50 to 80 gm.

or more weeks of freedom or washout from any medications known to influence LUTS before enrollment.

mental and physical capacity to understand and fill out the study questionnaires.

You may not qualify if:

contraindications to Sildosin or Tadalafil.
diagnosis of prostate cancer.
possible presence of urinary infection, neurogenic bladder, stone bladder, refractory retention, hematuria of prostate origin or any cause for surgical intervention.
clinically significant cardiovascular, hepatic, or renal disorders.
cataract surgery planned during the study period.

Contact the study team to confirm eligibility.

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

October 1, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

October 6, 2020

Record last verified: 2020-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04577040
Data provider: ClinicalTrials.gov
Source updated: 2020-10-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:51 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

1

2

3

4

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record