Phase 4
Completed N=635
A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction
Source: ClinicalTrials.gov NCT02224846 ↗Enrolled (actual)
635
Serious AEs
5.1%
Results posted
Oct 2017
Primary outcomePrimary: Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) — 33.8; 35.9 Percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) |
33.8; 35.9 | — |
| PRIMARY Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation |
1.4; 0.7 | — |
| SECONDARY Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score |
4.5; 6.2; 6.1; 7.4 | — |
| SECONDARY Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments |
8.2; 7.9; 8.1; 7.9; 8.6; 8.3 | — |
| SECONDARY Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary |
81.3; 86.7; 88.2; 91.7; 41.2; 49.5 | — |
| SECONDARY Percentage of Participants Achieving Normal Erectile Functioning |
22.2; 30.9; 31.6; 37.6 | — |
| SECONDARY Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments |
38.2; 42.3; 44.1; 43.5; 44.6; 43.7 | — |
| SECONDARY Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2 |
89.6; 95.7; 96.6; 97.5; 96.8; 95.7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02224846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.