Study of effects of testosterone replacement therapy in hypogonadal men with type 2 diabetes mellitus
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2019/09/021175
- Lead Sponsor
- Dr Ronak Gandhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patient age between 30 -60 years with symptoms of hypogonadism using the Aging Male Symptom Scale (AMS) score >=27 or the presence of following three sexual symptoms
Decreased sexual interest
Absent or rare morning erections and
Erectile dysfunction
Patientâ??s morning (7am-9am) serum total testosterone level <12 nmol/
Following patients will be excluded
Patient suffering from severe debilitating disease
History of prostate or breast cancer
Elevated hematocrit (PCV >48%)
Elevated prostate-specific antigen (PSA >4.0 ng/ml; PSA >3 with a high risk)
PSA increase >1.4ng/ml within any 12 month period
Palpable prostate nodule and induration on digital rectal examination (DRE)
Severe obstructive sleep apnea (OSA)
Severe lower urinary tract symptoms (LUTS) (International Prostate Symptom Score [IPSS] >19 )
Previously treated hypogonadism
Acute coronary event in last 6 months
Chronic obstructive lung disease
Recent use of PDE-5 inhibitors (within last 6 months)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method