Home » Trials » SLCTR/2007/011
Controlled trial of sildenafil citrate (Cupid) in diabetes patients with erectile dysfunction
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SLCTR Registration Number
SLCTR/2007/011
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
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)
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
Treatment
Study Phase
Not Available
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
2007-01-30
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Cupid tablets donated by Lanka Medical (Imports) Ltd, Colombo 1 and State Pharmaceuticals Manufacturing Corporation, Ratmalana
Regulatory approvals
Status
Approved
Date of Approval
2005-07-20
Approval number
ERC/05-014
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Sri Lanka Medical Association, |
| Institutional Address: | No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka |
| Telephone: | +94-11-2693324 |
| Email: | erc.slma@gmail.com |
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
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
