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Clinical Trials/CTRI/2019/09/021175
CTRI/2019/09/021175
Recruiting
Phase 4

The Effects Of Testosterone Replacement Therapy On Sexual Functions And Cardiovascular Risk Factors In Hypogonadal Men With Type 2 Diabetes

Dr Ronak Gandhi0 sites0 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Dr Ronak Gandhi
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Dr Ronak Gandhi

Eligibility 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/

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

Outcomes

Primary Outcomes

Not specified

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