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Trial History Detail on 2011-04-13

CUHK_CCT00162

2008-05-07

Prospective

nil

nil

nil

nil

Lee Chui Ping

622B, Li Choh Ming BMSB, The Chinese University of HK

26096819

cplee@cuhk.edu.hk cplee@cuhk.edu.hk

School of Pharmacy, CUHK

Lee Chui Ping

622B, Li Choh Ming BMSB, The Chinese University of HK

26096819

cplee@cuhk.edu.hk cplee@cuhk.edu.hk

School of Pharmacy, CUHK

Use of niacin for erectile dysfunction in patients with concomitant hyperlipidaemia

Use of niacin for erectile dysfunction in patients with concomitant hyperlipidaemia

Use of niacin for erectile dysfunction in patients with concomitant hyperlipidaemia

Hong Kong, China

Yes

2007-08-07

erectile dysfunction

Drug

niacin

12 wks

placebo

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 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.

18

80

Male

Interventional

Randomized

Placebo

Double-blind

Parallel

2008-05-14

157

Complete

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 outcome measurements include the 5 functional domains of the IIEF, the Life Satisfaction Checklist,13 and change in lipid panels.

No

2011-04-13

ChiCTR-TRC-09000722

2010-05-04


Yes

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