NCT04807231

Brief Summary

Currently, the gold standard to obtain bioavailable testosterone results is radioimmunoassay (RIA). However, this assay requires specific equipment. Giton in 2006 proposed an optimized calculation of the Vermeulen equation, the results of which seem to be well correlated with those obtained by RIA. The aim of this study is to determine if the bioavailable testosterone levels determined by both methods are similar in order to replace the usual RIA assay of bioavailable testosterone by this calculation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

3 years

First QC Date

March 11, 2021

Last Update Submit

April 11, 2023

Conditions

TestosteroneAndrogens

Keywords

testosteroneandrogensmenwomen

Outcome Measures

Primary Outcomes (1)

  • Concordance between RIA and calculated testosterone level

    Concordance between RIA and calculated testosterone level

    2 years

Interventions

Blood withdrawalBIOLOGICAL

Blood withdrawal in order to perform a bioavailable testosterone RIA (Radio-Immuno Assay).

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of this study is a unique cohort of 270 patients, male and female, aged between 18 and 90 (included). These patients have been included if there were being prescribed bioavailable testosterone by their physician in routine.

You may qualify if:

  • Every men and women aged between 18 and 90 can be included

You may not qualify if:

  • insufficient sample
  • sample not send for RIA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample in order to perform a bioavailable testosterone Radio-Immuno Assay

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Central Study Contacts

Marion SOYEZ, DR

CONTACT

03 22 08 71 02Soyez.Marion@chu-amiens.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 19, 2021

Study Start

March 11, 2021

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)