erectile dysfunction
Conditions
Interventions
Two groups:niacin 12 weeks versus placebo
Sponsors
None listed
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects who are male older than or equal to 18 years old and in a steady relationship with the same female partner for more than 6 months, with a documented history of hyperlipidaemia and ED (defined as a consistent change in the quality of erection that adversely affects the subject's satisfaction with sexual intercourse) of any severity or aetiology (i.e. psychogenic, organic, or mixed) may be included. Subjects with history of PDE 5-inhibitor use can be included in the study as long as they are willing to undergo a 2-week washout period. They could not use any other form of ED treatment for the duration of the study.
Exclusion criteria
Exclusion criteria: Exclusion criteria Subjects with untreated endocrine disease (e.g. hypogonadism); a history of radical prostatectomy (except nerve-sparing with residual erectile function) or other pelvic surgery; clinically significant penile deformity; a history of penile implant; significant renal (sCr> 150 micromol/L) or liver disease (AST/ALT > 3 times upper limit of normal); a haemoglobin A1C of >13% should be excluded from the study. Patients who take aspirin or NSAIDs on a regular basis will also be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measurements will be questions 3 (frequency of penetration) and 4 (frequency of maintained erections after penetration) of the International Index of Erectile Function (IIEF).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measurements include the 5 functional domains of the IIEF, the Life Satisfaction Checklist,13 and change in lipid panels.; | — |
Countries
China
Contacts
Public ContactLee Chui Ping
Outcome results
None listed