| Trial ID: | L4509 |
| Source ID: | NCT01468519
|
| Associated Drug: |
Insulin
|
| Title: |
Exploratory CSII Trial on Erectile Dysfunction in T2DM Patients
|
| Acronym: |
ECSIITED
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Erectile Dysfunction
|
| Interventions: |
DRUG: Insulin|DRUG: Insulin
|
| Outcome Measures: |
Primary: Change in total International Index of Erectile Function (IIEF) score from baseline to six months, IIEF quetionnaire is a standardised and validated 15-item self-evaluation scale that provides pre-post treatment clinic evaluations of erectile function, orgasmic function, sexual desire, satisfaction in sexual intercourse and general satisfaction, baseline and six months | Secondary: Global assessment question on erectile function, Global assessment question (GAQ), "Has the treatment you have been having improved your erections? (yes/no).", baseline and 6 months
|
| Sponsor/Collaborators: |
Sponsor: Jothydev's Diabetes and Research Centre
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-01
|
| Completion Date: |
2014-11
|
| Results First Posted: |
|
| Last Update Posted: |
2014-12-11
|
| Locations: |
Jothydev's Diabetes & Research Center, Thiruvananthapuram, Kerala, 695032, India
|
| URL: |
https://clinicaltrials.gov/show/NCT01468519
|
