Can Biotin Supplementation be Used to Mask hCG Abuse?

NCT05450900 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-02-03

No results posted yet for this study

Summary

This sponsor is an anti-doping laboratory tasked with testing athlete samples for prohibited substances by the World Anti-Doping Agency and other agencies.

This study is intended to measure:

1. Urinary/serum hCG (human chorionic gonadotropin) and urinary biotin concentrations in both treatment groups before, during, and after hCG intervention using standard immunoassay methods
2. To monitor hCG in both treatment groups before and after diafiltration of urine samples prior to analysis
3. To compare urinary and serum detectability (detection window, sensitivity) of hCG abuse in the hCG-only group compared to the hCG + biotin group

Conditions

  • Healthy

Interventions

DRUG

Choriogonadotropin Alpha

drug, active

DIETARY_SUPPLEMENT

biotin

supplement, oral

OTHER

Microcellulose filler

supplement, oral

Sponsors & Collaborators

  • Sports Medicine Research and Testing Laboratory

    lead INDUSTRY

Principal Investigators

  • Andre Crouch, MD · Sports Medicine Research and Testing Laboratory

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-27
Primary Completion
2023-02-02
Completion
2023-02-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05450900 on ClinicalTrials.gov