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A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tadalafil
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

22 Years - 69 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a history of erectile dysfunction for at least 3 months.
  • Are sexually active and willing to remain sexually active with the same female partner during the study.
  • Are willing to have 4 or more attempts of sexual intercourse with female partner between screening and first treatment start day.
  • Are willing to stay away from any other medicines that the participants were already taking for erectile dysfunction during this study period.

Exclusion Criteria:

  • Have erectile dysfunction, which is caused by any other primary sexual disorder.
  • Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central nervous system (study doctor will discuss with participants).
  • Have a penis deformity or penile implant that in the opinion of the participants' doctor is significant.
  • Have human immunodeficiency virus (HIV) infection.
  • Are using certain kinds of medicines, which are not allowed in this study.
  • Are allergic to tadalafil.
  • Are planning to father a baby or are in a relationship with a pregnant partner.
  • Are participating or discontinued participation in the past 30 days from any another clinical trial, which is not compatible with this trial.
  • Have participated or discontinued from any other tadalafil clinical trial.
  • Have a history of drug, alcohol, or substance abuse within the past 6 months.

Sites / Locations

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

2.5 mg/5 mg tadalafil

5 mg tadalafil

Arm Description

2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).

5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).

Outcomes

Primary Outcome Measures

Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation
Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Secondary Outcome Measures

Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.
Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.
Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.
Percentage of Participants Achieving Normal Erectile Functioning
Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 1 and Month 3.
Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments
Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 6 and Month 12.
Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2
Participants with "yes" responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity?

Full Information

First Posted
August 20, 2014
Last Updated
September 5, 2019
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02224846
Brief Title
A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction
Official Title
Postmarketing Surveillance Study: A Randomized, Open-Label, 3-Month Interventional Study of Tadalafil Effectiveness (2.5 mg and 5 mg) and Long-Term Safety Administered Once Daily in Chinese Men With Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the study drug, taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED). The study will last about up to 25 months for each participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
635 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2.5 mg/5 mg tadalafil
Arm Type
Experimental
Arm Description
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
Arm Title
5 mg tadalafil
Arm Type
Experimental
Arm Description
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Other Intervention Name(s)
LY450190
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
Description
A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time Frame
Baseline through Month 12
Title
Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation
Description
Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time Frame
Baseline through Month 12
Secondary Outcome Measure Information:
Title
Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score
Description
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.
Time Frame
Baseline, Month 1; Baseline, Month 3
Title
Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments
Description
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.
Time Frame
Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24
Title
Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
Description
Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.
Time Frame
Month 1, Month 3
Title
Percentage of Participants Achieving Normal Erectile Functioning
Description
Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 1 and Month 3.
Time Frame
Month 1, Month 3
Title
Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments
Description
Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 6 and Month 12.
Time Frame
Month 6, Month 12, Month 18, Month 24
Title
Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2
Description
Participants with "yes" responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity?
Time Frame
Month 3, Month12, Month 24

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a history of erectile dysfunction for at least 3 months. Are sexually active and willing to remain sexually active with the same female partner during the study. Are willing to have 4 or more attempts of sexual intercourse with female partner between screening and first treatment start day. Are willing to stay away from any other medicines that the participants were already taking for erectile dysfunction during this study period. Exclusion Criteria: Have erectile dysfunction, which is caused by any other primary sexual disorder. Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central nervous system (study doctor will discuss with participants). Have a penis deformity or penile implant that in the opinion of the participants' doctor is significant. Have human immunodeficiency virus (HIV) infection. Are using certain kinds of medicines, which are not allowed in this study. Are allergic to tadalafil. Are planning to father a baby or are in a relationship with a pregnant partner. Are participating or discontinued participation in the past 30 days from any another clinical trial, which is not compatible with this trial. Have participated or discontinued from any other tadalafil clinical trial. Have a history of drug, alcohol, or substance abuse within the past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
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
ZIP/Postal Code
130021
Country
China
Facility Name
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
ZIP/Postal Code
410011
Country
China
Facility Name
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
ZIP/Postal Code
610083
Country
China
Facility Name
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
ZIP/Postal Code
400037
Country
China
Facility Name
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
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
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
Guangzhou
ZIP/Postal Code
510180
Country
China
Facility Name
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
ZIP/Postal Code
310003
Country
China
Facility Name
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
ZIP/Postal Code
230022
Country
China
Facility Name
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
ZIP/Postal Code
210008
Country
China
Facility Name
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
Qingdao
ZIP/Postal Code
266071
Country
China
Facility Name
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
ZIP/Postal Code
200092
Country
China
Facility Name
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 City
ZIP/Postal Code
215004
Country
China
Facility Name
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
ZIP/Postal Code
325035
Country
China
Facility Name
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
ZIP/Postal Code
430030
Country
China
Facility Name
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
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
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
Yinchuan
ZIP/Postal Code
750004
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
IPD Sharing URL
https://vivli.org/

Learn more about this trial

A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction

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