To understand the disease burden of symptomatic Testosterone deficiency in male patients of Type 2 Diabetes Mellitus in India.

Not Applicable

• Conditions: Health Condition 1: null- Indian Males with Type 2 Diabetes Mellitus who may or may not be suffering with Hypogonadism.

• Registration Number: CTRI/2013/12/004252
• Lead Sponsor: MSD Pharmaceuticals Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 897

Inclusion Criteria

1.Males between the age of 30 to 59 years (both inclusive), with a confirmed diagnosis of Type-2 diabetes mellitus

2.Each subject must be willing to provide written informed consent

Exclusion Criteria

1.Type 1 diabetes patients

2.Patients receiving testosterone replacement therapy

3.Patients suffering from any chronic liver disease, renal disease, advanced malignancy, debilitating diseases like tuberculosis, malabsorption, inflammatory bowel disease, pyrexia of unknown origin, AIDS, sickle cell disease, autoimmune diseases like rheumatoid arthritis, ankylosing spondylitis

4.Patients with known causes of hypogonadism including:

o Hypergonadotropic hypogonadism or primary hypogonadism: testicular failure due to genetic disorders (e.g., Klinefelterâ??s syndrome), orchitis, trauma, castration, radiation, chemotherapy, or undescended testes

o Hypogonadotropic hypogonadism, central hypogonadism, or secondary hypogonadism: patients with gonadotropin deficiency or dysfunction as a result of disease or damage to the hypothalamic-pituitary axis (e.g. Kallmannâ??s syndrome, tumour, trauma, radiation, sarcoidosis, or tuberculosis).

5.Patients on medications, or have taken medications in last 6 months, known to cause hypogonadal states like ketoconazole, anabolic steroids, corticosteroids, spironolactone, cimetidine, phenytoin, GnRH analogue, flutamide and narcotic addicts (heroin).

6.Patients having severe psychological symptoms

7.Patients currently enrolled in another clinical trial

8.Patients having any clinically significant condition or situation, other than the condition being studied that, in the opinion of the Investigator, would interfere with the study evaluations or optimal participation in the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified