Phase 3
N=909
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
Benign Prostate Hyperplasia · Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01937871 ↗Enrolled (actual)
909
Serious AEs
1.5%
Results posted
Feb 2017
Primary outcome: Primary: Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 — -4.08; -5.49; -4.92 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 5 mg Tadalafil (Drug); Placebo (Drug); 0.2 mg Tamsulosin (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 |
-4.08; -5.49; -4.92 | — |
| SECONDARY Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12 |
1.88; 5.24; 2.64 | — |
| SECONDARY Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12 |
10.90; 23.87; 6.84 | — |
| SECONDARY Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12 |
15.96; 36.62; 17.42 | — |
| SECONDARY Change From Baseline in IPSS at Week 12 |
-4.08; -5.49; -4.92 | — |
| SECONDARY Change From Baseline in Uroflowmetry Measures at Week 12 |
1.5; 1.9; 2.0 | — |
| SECONDARY Change From Baseline in Postvoid Residual Volume (PVR) at Week 12 |
-6.3; -3.8; -9.5 | — |
| SECONDARY Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12 |
-1.68; -2.01; -1.90 | — |
| SECONDARY Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12 |
-2.42; -3.49; -3.07 | — |
| SECONDARY Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12 |
-0.85; -0.98; -1.00 | — |
| SECONDARY Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12 |
0; 0; 0; 3; 2; 0 | — |
| SECONDARY Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12 |
0; 1; 0; 2; 0; 0 | — |
| SECONDARY Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12 |
0.62; 1.54; 0.71 | — |
| SECONDARY Change From Baseline in IIEF Intercourse Satisfaction at Week 12 |
-0.05; 1.08; 0.41 | — |
| SECONDARY Change From Baseline in IIEF Orgasmic Function at Week 12 |
0.28; 1.31; 0.57 | — |
| SECONDARY Change From Baseline in IIEF Sexual Desire at Week 12 |
0.46; 1.12; 0.28 | — |
| SECONDARY Change From Baseline in IIEF Subscores at Week 12 |
0.28; 0.87; 0.39; 0.30; 0.87; 0.50 | — |
| SECONDARY Change From Baseline in Total IPSS at Week 4 and Week 8 |
-2.99; -4.10; -3.92; -3.50; -4.85; -4.44 | — |
| SECONDARY Change From Baseline in IIEF EF at Week 4 and Week 8 |
1.23; 4.50; 1.43; 1.51; 4.77; 2.19 | — |
| SECONDARY Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8 |
5.43; 20.53; 6.21; 10.79; 23.22; 7.42 | — |
| SECONDARY Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8 |
7.41; 23.38; 9.57; 14.08; 32.27; 14.98 | — |
| SECONDARY Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at Week 2 |
-2.19; -3.40; -3.20 | — |
Summary
The purpose of this study is to see whether tadalafil can reduce the signs and symptoms in men with Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia-Lower Urinary Tract Symptoms (BPH-LUTS) and improve their quality of life.
Eligibility Criteria
Main Inclusion Criteria:
- Present with a history of ED and signs and symptoms of BPH.
- Are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study.
Main Exclusion Criteria:
- Current treatment with nitrates.
- Prostate-specific antigen (PSA) greater than 10.0 nanogram (ng)/mL at 1st screening.
- PSA greater than or equal to 4.0 to less than or equal to 10.0 ng/mL at 1st screening if prostate malignancy has not been ruled out to the satisfaction of a urologist
- Suffering from other urinary disease like cancer, or infection
- Serious cardiovascular disease
- History of significant renal insufficiency
Data sourced from ClinicalTrials.gov (NCT01937871). 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.