NCT02224846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
635

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Typical duration for phase_4

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
6 months until next milestone

Results Posted

Study results publicly available

October 27, 2017

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

August 20, 2014

Results QC Date

May 25, 2017

Last Update Submit

September 5, 2019

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline through Month 12

  • 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.

    Baseline through Month 12

Secondary Outcomes (6)

  • Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score

    Baseline, Month 1; Baseline, Month 3

  • Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments

    Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24

  • Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary

    Month 1, Month 3

  • Percentage of Participants Achieving Normal Erectile Functioning

    Month 1, Month 3

  • Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments

    Month 6, Month 12, Month 18, Month 24

  • +1 more secondary outcomes

Study Arms (2)

2.5 mg/5 mg tadalafil

EXPERIMENTAL

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).

Drug: Tadalafil

5 mg tadalafil

EXPERIMENTAL

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

Drug: Tadalafil

Interventions

TadalafilDRUG

Administered orally

Also known as: LY450190
2.5 mg/5 mg tadalafil5 mg tadalafil

Eligibility Criteria

Age22 Years - 69 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

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, 100020, China

Location

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, 130021, China

Location

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, 410011, China

Location

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, 610083, China

Location

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, 400037, China

Location

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.

Fuzhou, 350001, China

Location

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.

Guangzhou, 510180, China

Location

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, 310003, China

Location

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, 230022, China

Location

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, 210008, China

Location

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.

Qingdao, 266071, China

Location

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, 200092, China

Location

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, 215004, China

Location

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, 325035, China

Location

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.

Wuhan, 430022, China

Location

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.

Wuhan, 430030, China

Location

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.

Yinchuan, 750004, China

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 25, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2017

Last Updated

September 23, 2019

Results First Posted

October 27, 2017

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
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.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
More information

Locations

CN(17)