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

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 19, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2023

Completed
Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

March 11, 2021

Last Update Submit

June 11, 2026

Conditions

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 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

Location

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

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

February 19, 2021

Primary Completion

February 18, 2023

Study Completion

February 18, 2023

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations