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

This study is currently recruiting participants.
Verified January 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: January 17, 2014
Last verified: January 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: February 2016
Estimated Primary Completion Date: February 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
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. Not yet 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. Not yet 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         
Korea, Republic of
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
Daegu, Korea, Republic of, 705-717
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
Goyang-Si, Korea, Republic of, 412-270
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
Incheon, Korea, Republic of, 400-711
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
Jeon Ju-City, Korea, Republic of, 561-712
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
Pusan, Korea, Republic of, 602-739
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
Seoul, Korea, Republic of, 134-701
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. Recruiting
Kaohsiung, Taiwan, 813
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
Kuei Shan Hsiang, Taiwan, 33305
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
Taipei, Taiwan, 100
Contact: Eli Lilly         
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: January 17, 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
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014