TESTOBIO: Comparison Between Calculated Bioavailable Testosterone Level With Radio-immunoassay Result.
Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT04807231
Collaborator
(none)
270
1
23.7
11.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
270 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Comparison Between Calculated Bioavailable Testosterone Level With Radio-immunoassay Result.
Actual Study Start Date
:
Mar 11, 2021
Anticipated Primary Completion Date
:
Mar 1, 2023
Anticipated Study Completion Date
:
Mar 1, 2023
Outcome Measures
Primary Outcome Measures
- Concordance between RIA and calculated testosterone level [2 years]
Concordance between RIA and calculated testosterone level
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Every men and women aged between 18 and 90 can be included
Exclusion Criteria:
-
insufficient sample
-
sample not send for RIA
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Amiens | Amiens | France | 80480 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire, Amiens
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT04807231
Other Study ID Numbers:
- PI2021_843_0044
First Posted:
Mar 19, 2021
Last Update Posted:
Mar 19, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens