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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01937871
First received: September 4, 2013
Last updated: August 29, 2014
Last verified: August 2014
  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 ]

Estimated Enrollment: 890
Study Start Date: September 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (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
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

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

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. Recruiting
Beijing, China, 100853
Contact: Eli Lilly         
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. Recruiting
Changsha, China, 410011
Contact: Eli Lilly         
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. Recruiting
Chengdu, China, 610072
Contact: Eli Lilly         
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. Recruiting
Chongqing, China, 400038
Contact: Eli Lilly         
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. Recruiting
Hangzhou, China, 310003
Contact: Eli Lilly         
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. Recruiting
Nanchang, China
Contact: Eli Lilly         
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. Recruiting
Nanjing, China, 210008
Contact: Eli Lilly         
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. Recruiting
Shanghai, China, 200040
Contact: Eli Lilly         
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. Recruiting
Suzhou, China, 215006
Contact: Eli Lilly         
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. Recruiting
Wenzhou, China, 325035
Contact: Eli Lilly         
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. Recruiting
Wu Han, China, 430030
Contact: Eli Lilly         
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. Recruiting
Xi'An, China, 710004
Contact: Eli Lilly         
Taiwan
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. Active, not recruiting
Kaohsiung, Taiwan, 813
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. Active, not recruiting
Kuei Shan Hsiang, Taiwan, 33305
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. Active, not recruiting
Taipei, Taiwan, 100
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

No publications provided

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: August 29, 2014
Health Authority: China: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan : Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 14, 2014