Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00162

2 Trial Registration Date

2008-05-07

i Registration Status

Prospective

3 Secondary IDs

nil

4 Source(s) of Funding

nil

5 Primary Sponsor

nil

6 Secondary Sponsor

nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Lee Chui Ping

ii Address

iii Phone

iv Email

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

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Lee Chui Ping

ii Address

iii Phone

iv Email

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

v Affiliation

vi Country

9 Official Scientific Title of the Study

Use of niacin for erectile dysfunction in patients with concomitant hyperlipidaemia

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Use of niacin for erectile dysfunction in patients with concomitant hyperlipidaemia

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2007-08-07

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

erectile dysfunction

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

niacin

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 wks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

placebo

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i 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 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.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-05-14

21 Target Sample Size

157

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

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).

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-13

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

nil

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Trial History Detail on 2009-11-19