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

Hypogonadism Clinical Trial

— DESTINY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437109
• Other study ID #: BH-DM-11-2017
• Status: Completed
• Start date: December 6, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: January 2019
• Source: Besins Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypogonadism
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Diagnostic Test:
• Laboratory tests
Testosterone HSBG Hb1Ac LH

Locations

Country	Name	City	State
Russian Federation	Central Clinical Hospital	Moscow
Russian Federation	ENC	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Besins Healthcare

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of hypogonadism in patients with T2DM	The prevalence of hypogonadism in patients with T2DM	2017-2018