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Completed

NCT Number: NCT03437109

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

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

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Key information

Age range

45 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Central Clinical Hospital, Moscow, Russia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Laboratory tests

Diagnostic Test

Testosterone HSBG Hb1Ac LH

Primary outcomes

  1. The prevalence of hypogonadism in patients with T2DM

    Time frame: 2017-2018

    The prevalence of hypogonadism in patients with T2DM

Sponsors and collaborators

Lead sponsor

Besins Healthcare

Industry

Registry information

Official study title

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

Acronym: DESTINY

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2018
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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