Clinical trial NCT01937871: A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
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 for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia and Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostate Hyperplasia
Erectile Dysfunction
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-09-10
Enrollment: 909
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in IPSS at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Uroflowmetry Measures at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Postvoid Residual Volume (PVR) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12
timeFrame: Week 12
measure: Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12
timeFrame: Week 12
measure: Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in IIEF Intercourse Satisfaction at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in IIEF Orgasmic Function at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in IIEF Sexual Desire at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in IIEF Subscores at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Total IPSS at Week 4 and Week 8
timeFrame: Baseline, Week 4; Baseline, Week 8
measure: Change From Baseline in IIEF EF at Week 4 and Week 8
timeFrame: Baseline, Week 4; Baseline, Week 8
measure: Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8
timeFrame: Baseline, Week 4; Baseline, Week 8
measure: Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8
timeFrame: Baseline, Week 4; Baseline, Week 8
measure: Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at Week 2
timeFrame: Baseline, Week 2
Other outcomes:
Locations:
city: Beijing
country: China
facility: 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.
city: Changchun
country: China
facility: 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.
city: Changsha
country: China
facility: 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.
city: Chengdu
country: China
facility: 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.
city: Chongqing
country: China
facility: 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.
city: Hangzhou
country: China
facility: 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.
city: Hefei
country: China
facility: 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.
city: Nanchang
country: China
facility: 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.
city: Nanjing
country: China
facility: 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.
city: Shanghai
country: China
facility: 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.
city: Suzhou
country: China
facility: 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.
city: Wenzhou
country: China
facility: 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.
city: Wu Han
country: China
facility: 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.
city: Xi'An
country: China
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: