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 or Health Condition(s) Studied

Erectile dysfunction in diabetes patients


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial 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


Phase


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)

  1. Relief of erectile dysfunction

    []

Secondary outcome(s)

  1. Patient and partner satisfaction

    []

Target number/sample size

75


Countries of recruitment

Sri Lanka


Anticipated start date

2006-03-01


Anticipated end date

2006-03-01


Date of first enrollment


Date of study completion


Recruitment status

Complete


Funding source

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



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:


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





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description


Study protocol available


Protocol version and date


Protocol URL


Results summary available


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results