Status:
COMPLETED
Exploratory CSII Trial on Erectile Dysfunction in T2DM Patients
Lead Sponsor:
Jothydev's Diabetes and Research Centre
Conditions:
Diabetes Mellitus, Type 2
Erectile Dysfunction
Eligibility:
MALE
25-65 years
Phase:
PHASE4
Brief Summary
Erectile dysfunction (ED) is a common form of organic sexual dysfunction in males with diabetes, with estimated incidence rates between 35 and 75%. Fifty percent of men with diabetes are afflicted wit...
Detailed Description
Background Erectile dysfunction (ED) is a common form of organic sexual dysfunction in males with diabetes, with estimated incidence rates between 35 and 75%. Fifty percent of men with diabetes are af...
Eligibility Criteria
Inclusion
- Male T2DM patients with HbA1c \< 9%
- Mild ED to Moderate ED as defined by International Index of Erectile Function (IIEF) questionnaire
- Able and willing to use insulin pumps for at least the duration of the study
Exclusion
- Severe dysfunction in IIEF Score or duration of ED more than 3 years
- Heart failure (class II - IV) or unstable cardiovascular disease; poorly controlled blood pressure (systolic \> 170 or \< 90 mmHg or diastolic \> 100 or \< 50 mmHg) or orthostatic hypotension
- Medications: Substance abuse, anticancer and steroid therapy
- Sexual dysfunction in partner, lack of stable relationship.
- History of radical prostatectomy or pelvic surgery, significant penile deformities, penile implants, or history of stroke or spinal-cord trauma.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01468519
Start Date
January 1 2012
End Date
November 1 2014
Last Update
December 11 2014
Active Locations (1)
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1
Jothydev's Diabetes & Research Center
Thiruvananthapuram, Kerala, India, 695032