Status:

COMPLETED

Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus

Lead Sponsor:

Besins Healthcare

Conditions:

T2DM (Type 2 Diabetes Mellitus)

Hypogonadism

Eligibility:

MALE

45-60 years

Brief Summary

The purpose of the study is to get data of prevalence of testosterone deficiency in patient with T2DM in Russian Federation

Detailed Description

Clinical and Epidemiological Characteristics and Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus Under Routine Clinical Practice (DESTINY)

Eligibility Criteria

Inclusion

  • Male 45-60 years old
  • Diagnosis of T2DM according to approved standards
  • Signed Informed Consent Form

Exclusion

  • Prepubertal hypogonadism of any genesis;
  • Sexual and developmental disorders;
  • Absence of at least one of the testicles;
  • Cryptorchidism, including in the anamnesis;
  • Injuries and / or surgical interventions on the genitals with loss of at least one of the testicles;
  • Established diagnosis of panhypopituitarism in accordance with current recommendations / standards;
  • Androgen therapy, administered at the time of the study or in the anamnesis;
  • Admission of anabolic steroids;
  • Alcoholism or drug addiction;
  • Insolvency.

Key Trial Info

Start Date :

December 6 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 1 2019

Estimated Enrollment :

554 Patients enrolled

Trial Details

Trial ID

NCT03437109

Start Date

December 6 2017

End Date

February 1 2019

Last Update

June 20 2019

Active Locations (2)

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Page 1 of 1 (2 locations)

1

ENC

Moscow, Russia, 117036

2

Central Clinical Hospital

Moscow, Russia, 121359