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

Sponsor
Besins Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT03437109
Collaborator
(none)
554
Enrollment
2
Locations
13.9
Actual Duration (Months)
277
Patients Per Site
20
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Laboratory tests

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)

Study Design

Study Type:
Observational
Actual Enrollment :
554 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical and Epidemiological Characteristics and Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus Under Routine Clinical Practice
Actual Study Start Date :
Dec 6, 2017
Actual Primary Completion Date :
Feb 1, 2019
Actual Study Completion Date :
Feb 1, 2019

Outcome Measures

Primary Outcome Measures

  1. The prevalence of hypogonadism in patients with T2DM [2017-2018]

    The prevalence of hypogonadism in patients with T2DM

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 60 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 ENC Moscow Russian Federation 117036
2 Central Clinical Hospital Moscow Russian Federation 121359

Sponsors and Collaborators

  • Besins Healthcare

Investigators

  • Study Chair: Marina SHESTAKOVA, academitian, ENC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Besins Healthcare
ClinicalTrials.gov Identifier:
NCT03437109
Other Study ID Numbers:
  • BH-DM-11-2017
First Posted:
Feb 19, 2018
Last Update Posted:
Jun 20, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypogonadism

Study Results

No Results Posted as of Jun 20, 2019