Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Injection testosterone undecanoate: Injection testosterone undecanoate 1000mg IM at 0, 6, 18, 30, 52 week
Control Intervention1: Nil: Nil
Control Intervention2: Not applicable: Not appl
Sponsors
Dr Ronak Gandhi
Eligibility
Inclusion criteria
Inclusion criteria: 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/L
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in AMS SCORE 2. Change in cardiovascular risk factors like lipid profile, HbA1c, HOMA-IR, Fasting plasma glucose, hscrp and CIMTTimepoint: 1. For AMS SCORE at 6, 18, 30, 42, 54 weeks 2. For lipid profile,Fasting plasma glucose, at at 6, 18, 30, 42, 54 weeks 4.for HbA1c, hscrp, HOMA-IR, CIMT at 54 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in IIEF scoreTimepoint: For IIEF score at 6, 18, 30, 42, 54 weeks | — |
Countries
India
Contacts
Public ContactDr Ronak Gandhi
MKCG Medical college, Berhampur, odisha
Outcome results
None listed