Phase 3
N=1,070
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
Benign Prostatic Hyperplasia · Enlarged Prostate
Bottom Line
View on ClinicalTrials.gov: NCT01139762 ↗Enrolled (actual)
1,070
Serious AEs
0.9%
Results posted
Feb 2013
Primary outcome: Primary: Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks — -5.18; -3.76 units on a scale — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tadalafil (Drug); Placebo (Drug); Finasteride (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks |
-5.18; -3.76 | 0.001 sig |
| SECONDARY Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks |
-3.95; -2.29; -5.51; -4.47 | — |
| SECONDARY Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks |
-1.27; -0.76; -1.74; -1.34; -2.00; -1.66 | 0.007 sig |
| SECONDARY Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks |
-0.63; -0.32; -0.95; -0.76; -1.10; -0.92 | <0.001 sig |
| SECONDARY Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks |
3.71; -1.14; 4.71; 0.63; 4.71; -0.02 | <0.001 sig |
| SECONDARY Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks |
0.91; -0.10; 1.38; 0.31; 1.61; 0.40 | <0.001 sig |
| SECONDARY Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks |
1.36; -0.46; 1.68; 0.08; 1.72; -0.26 | <0.001 sig |
| SECONDARY Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks |
0.90; -0.63; 1.08; 0.18; 0.89; -0.18 | <0.001 sig |
| SECONDARY Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks |
0.46; -0.47; 0.56; -0.23; 0.71; -0.05 | <0.001 sig |
| SECONDARY Patient Global Impression of Improvement (PGI-I) at 26 Weeks |
21; 29; 124; 82; 102; 112 | 0.034 sig |
| SECONDARY Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks |
2.0; 2.1 | 0.031 sig |
| SECONDARY Clinician Global Impression of Improvement (CGI-I) at 26 Weeks |
23; 22; 129; 97; 98; 106 | 0.328 |
| SECONDARY Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks |
-24.8; -23.1 | 0.157 |
| SECONDARY Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks |
0.42; -0.32; 0.72; 0.04; 0.68; -0.07 | <0.001 sig |
Summary
The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.
Eligibility Criteria
Inclusion Criteria
- Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:
- All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
- Overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
- Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
- Finasteride or dutasteride use at any time.
- Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before receiving study drug.
- Have prostate enlargement measured by ultrasound at screening.
Exclusion Criteria
- Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer [Prostate-specific antigen (PSA) greater than 10 nanograms/milliliter (ng/mL) at the start of study].
- Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
- Have problems with kidneys, liver, or nervous system
- Have uncontrolled diabetes
- Have had a stroke or a significant injury to brain or spinal cord.
- Have scheduled or planned surgery during the course of the study.
Data sourced from ClinicalTrials.gov (NCT01139762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.