A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01937871
First received: September 4, 2013
Last updated: January 26, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Prostatic Hyperplasia
Erectile Dysfunction
Drug: 5 mg Tadalafil
Drug: Placebo
Drug: 0.2 mg Tamsulosin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in IPSS at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Uroflowmetry Measures at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Postvoid Residual Volume (PVR) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in IPSS Storage (Irritative) Subscore at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in IPSS Voiding (Obstructive) Subscore at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in IPSS Quality of Life (QoL) Index at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Improvement (PGI-I) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Clinician Global Impression of Improvement (CGI-I) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in IIEF Overall Satisfaction at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in IIEF Intercourse Satisfaction at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in IIEF Orgasmic Function at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in IIEF Sexual Desire at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in IIEF Subscores at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Total IPSS at Week 4 and Week 8 [ Time Frame: Baseline, Week 4; Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Change from Baseline in IIEF EF at Week 4 and Week 8 [ Time Frame: Baseline, Week 4; Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8 [ Time Frame: Baseline, Week 4; Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8 [ Time Frame: Baseline, Week 4; Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Change from Baseline in modified IPSS at Week 2 [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]

Enrollment: 855
Study Start Date: September 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
Drug: Placebo
Administered orally
Experimental: 5 mg Tadalafil
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 16 weeks.
Drug: 5 mg Tadalafil
Administered orally
Other Name: LY450190
Drug: Placebo
Administered orally
Active Comparator: 0.2 mg Tamsulosin
Tamsulosin 0.2 mg capsule administered once daily by mouth for 16 weeks.
Drug: Placebo
Administered orally
Drug: 0.2 mg Tamsulosin
Administered orally

  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01937871

Locations
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, 100020
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, 130021
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, 410011
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, 610072
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, 400038
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, 310003
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, 230022
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, 210008
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, 200040
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, 215006
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, 325035
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, 430030
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, China, 710004
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01937871     History of Changes
Other Study ID Numbers: 14393  H6D-MC-LVJE 
Study First Received: September 4, 2013
Last Updated: January 26, 2016
Health Authority: China: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Hyperplasia
Erectile Dysfunction
Prostatic Hyperplasia
Pathologic Processes
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Prostatic Diseases
Tadalafil
Tamsulosin
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 29, 2016