Erectile Dysfunction Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel-Design, Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once-Daily Dosing in Men With Signs and Symptoms of Benign Prostatic Hyperplasia and Erectile Dysfunction
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.
| Status | Completed |
| Enrollment | 855 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 45 Years and older |
| Eligibility |
Inclusion Criteria: - Present with signs and symptoms of BPH and have a history of ED - Willing to attend this clinical trial Exclusion Criteria: - Suffering from other urinary disease like cancer, or infection - Serious cardiovascular disease - History of significant renal insufficiency |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Beijing | |
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Changchun | |
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Changsha | |
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chengdu | |
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chongqing | |
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hangzhou | |
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hefei | |
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nanchang | |
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nanjing | |
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shanghai | |
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Suzhou | |
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wenzhou | |
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wu Han | |
| China | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Xi'An |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change from Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change from Baseline in IPSS at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change from Baseline in Uroflowmetry Measures at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change from Baseline in Postvoid Residual Volume (PVR) at Week 12 | Baseline, Week 12 | Yes | |
| Secondary | Change from Baseline in IPSS Storage (Irritative) Subscore at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change from Baseline in IPSS Voiding (Obstructive) Subscore at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change from Baseline in IPSS Quality of Life (QoL) Index at Week 12 | Baseline, Week 12 | No | |
| Secondary | Patient Global Impression of Improvement (PGI-I) at Week 12 | Week 12 | No | |
| Secondary | Clinician Global Impression of Improvement (CGI-I) at Week 12 | Week 12 | No | |
| Secondary | Change from Baseline in IIEF Overall Satisfaction at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change from Baseline in IIEF Intercourse Satisfaction at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change from Baseline in IIEF Orgasmic Function at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change from Baseline in IIEF Sexual Desire at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change from Baseline in IIEF Subscores at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change from Baseline in Total IPSS at Week 4 and Week 8 | Baseline, Week 4; Baseline, Week 8 | No | |
| Secondary | Change from Baseline in IIEF EF at Week 4 and Week 8 | Baseline, Week 4; Baseline, Week 8 | No | |
| Secondary | Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8 | Baseline, Week 4; Baseline, Week 8 | No | |
| Secondary | Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8 | Baseline, Week 4; Baseline, Week 8 | No | |
| Secondary | Change from Baseline in modified IPSS at Week 2 | Baseline, Week 2 | No |
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