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Phosphodiesterase Type 5 Inhibitor

5 milligrams (mg) Tadalafil for Enlarged Prostate

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4 and week 8
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

Summary

The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for 8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate transition zone.

Eligible Conditions
  • Enlarged Prostate

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4 and week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 and week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone
Secondary study objectives
Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck
Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck
Change From Baseline to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone

Side effects data

From 2017 Phase 4 trial • 635 Patients • NCT02224846
9%
Viral upper respiratory tract infection
3%
Periodontitis
3%
Prostatitis
2%
Alanine aminotransferase increased
2%
Upper respiratory tract infection
2%
Abdominal pain upper
2%
Chronic gastritis
2%
Blood uric acid increased
2%
Insomnia
1%
Enteritis
1%
Rhinitis allergic
1%
Sleep disorder
1%
Rhinitis
1%
Eczema
1%
Pharyngitis
1%
Influenza
1%
Diabetes mellitus
1%
Gout
1%
Back pain
1%
Gastritis
1%
Urinary tract infection
1%
Dizziness
1%
Epistaxis
1%
Renal cyst
1%
Gastric polyps
1%
Gastrooesophageal reflux disease
1%
Nephrolithiasis
1%
Hypertension
1%
Pyrexia
1%
Large intestine polyp
1%
Abdominal distension
1%
Abdominal pain
1%
Dental caries
1%
Diarrhoea
1%
Gamma-glutamyltransferase increased
1%
Headache
1%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
2.5 mg/5 mg Tadalafil
5 mg Tadalafil

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 5 milligrams (mg) TadalafilExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tadalafil
FDA approved

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,669 Previous Clinical Trials
3,228,644 Total Patients Enrolled
1 Trials studying Enlarged Prostate
696 Patients Enrolled for Enlarged Prostate
Study DirectorEli Lilly and Company
1,385 Previous Clinical Trials
426,294 Total Patients Enrolled
1 Trials studying Enlarged Prostate
696 Patients Enrolled for Enlarged Prostate
~6 spots leftby Nov 2025
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