Home » Trials » SLCTR/2007/011


Controlled trial of sildenafil citrate (Cupid) in diabetes patients with erectile dysfunction -

SLCTR Registration Number

SLCTR/2007/011


Date of Registration

21 Sep 2007

The date of last modification

Nov 21, 2017


Trial Status



Application Summary


Scientific Title of Trial

Controlled trial of sildenafil citrate (Cupid) in diabetes patients with erectile dysfunction


Public Title of Trial

Sildenafil citrate in erectile dysfunction in diabetes


Disease of Health Condition(s) Studied

Erectile dysfunction in diabetes patients


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

None


Any other number(s) assigned to the trial and issuing authority

ERC/05-014 (Ethics Review Committee of the Sri Lanka Medical Association)


Trial Details


What is the research question being addressed?

How effective is sildenafil citrate(Cupid) in erectile dysfunction in diabetes ?


Type of study

Interventional


Study design

Allocation

Non-randomized controlled trial


Masking

Single blinded


Control

Placebo


Assignment

Crossover


Purpose


Intervention(s) planned

Giving sildenafil citrate (Cupid) or placebo


Inclusion criteria

All diabetes patients with erectile dysfunction


Exclusion criteria

Patients taking nitrates for ischemic heart disease



Primary outcome(s)

Relief of erectile dysfunction


Primary outcome(s) - Time of assessment(s)


Secondary outcome

Patient and partner satisfaction


Secondary outcome(s) - Time of assessment(s)

Patient and partner satisfaction



Target number/sample size

75


Countries of recruitment

Sri Lanka


Anticipated start date

2006-03-01


Anticipated end date

2007-01-30


Recruitment status

Complete


State of ethics review approval

Approved by the Ethics Review Committee of the Sri Lanka Medical Association (ERC/05-014)


Funding source

Cupid tablets donated by Lanka Medical (Imports) Ltd, Colombo 1 and State Pharmaceuticals Manufacturing Corporation, Ratmalana



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Colvin Goonaratna
Professor
Faculty of Medicine Kynsey Road Colombo 8
4612643
0773-488289
4612643
colvin_cg@yahoo.com

Contact Person for Public Queries

Keshani Warusavitana
Doctor
Faculty of Medicine Kynsey Road Colombo 8
2695300


keshani.warusawithana@gmail.com


Primary study sponsor/organization

Faculty of Medicine, Colombo

Kynsey Road Colombo 8
2695300
4612643

Secondary study sponsor (If any)

None