Can Biotin Supplementation be Used to Mask hCG Abuse?

NCT05450900 | Completed Early Phase 1 FDA Drug

• 1 other identifier: SMRTL-2022_01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To monitor hCG in both treatment groups before and after diafiltration of urine samples prior to analysis
3. 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

Outcome Measures

Primary Outcomes (2)

• 1. Urinary hCG and biotin concentrations

  Urinary hCG concentration will be measured on different analytical platforms (Abbott, Roche, Siemens) that are dependent or not dependent on biotin-streptavidin chemistry for hCG measurement. Urinary biotin concentration will be measured using mass spectrometric techniques. Measured hCG concentrations, especially those during and after the dosing of Ovidrel, will be assessed in combination with the biotin concentration to understand the masking effect of biotin on urinary hCG measurement as it relates to anti-doping.

  6 months

• 2. HPT-related hormone measurements in serum; biotin measurements in serum

  hCG, LH (luteinizing hormone), FSH (follicle stimulating hormone), testosterone, SHBG (sex hormone binding globulin), and estradiol will be measured in serum before and after treatment with Ovidrel. Changes in each of these compounds will be compared to individual baseline values established prior to Ovidrel use to understand the drug effects. hCG and LH will be measured on analytical platforms known to be affected by biotin interference, and all analytes (including hCG and LH) will be measured on an analytical platform not affected by biotin interference.

  6 months

Secondary Outcomes (3)

• 1. Detection window of hCG following use

  6 months

• 2. Urinary testosterone/epitestosterone ratio measurement

  6 months

• 3. CBC measurements as they relate to the Athlete Biological Passport

  6 months

Study Arms (2)

Cohort 1

ACTIVE COMPARATOR

hCG plus biotin supplement

Drug: Choriogonadotropin Alpha; Dietary Supplement: biotin

Cohort 2

PLACEBO COMPARATOR

hCG plus placebo supplement

Drug: Choriogonadotropin Alpha; Other: Microcellulose filler

Interventions

Choriogonadotropin Alpha DRUG

drug, active

Also known as: ovidrel, hCG

Cohort 1; Cohort 2

biotin DIETARY_SUPPLEMENT

supplement, oral

Also known as: vitamin B7

Cohort 1

Microcellulose filler OTHER

supplement, oral

Also known as: placebo, capsules

Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Identifies as male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be healthy males aged 18 or older
• Participants must be actively exercising individuals

You may not qualify if:

• Individuals below the age of 18 or greater than the age of 55 on the day of enrollment
• Individuals currently enrolled in a registered testing pool for anti-doping purposes
• Individuals unwilling to provide blood or urine samples
• Individuals that are not actively exercising
• Individuals currently using testosterone or undergoing hypogonadism or hypoandrogenism treatment, or have within the previous 3 months
• Individuals at risk for testicular or prostate cancer, as determined by the physician, or with a history of hormone dependent tumors of the reproductive tract and accessory organs (such as prostatic carcinoma, testicular cyst, or breast cancer)
• Individuals that show a high risk of heart attack, blood clots or cardiovascular disease, as defined by the physician, or who are currently using anticoagulant medications
• Individuals with a history of cardiac, renal or hepatic disease, as defined by the physician
• Individuals with a history of prostatic hyperplasia, venous thromboembolism, stroke, edema, or sleep apnea
• Individuals that are diabetic or are currently taking a diabetic medicine
• Individuals with epilepsy
• Individuals with a known allergy to hamster protein or with hypersensitivity to hCG preparations or excipients
• Individuals with a history of aggressive behavior or suicidality

Sponsors & Collaborators

• Sports Medicine Research and Testing Laboratory: lead

Study Sites (1)

Sports Medicine Research and Testing Laboratory

Salt Lake City, Utah, 84095, United States

Location

Related Publications (1)

• Goodrum JM, Nair VS, Moore C, Crouch AK, Eichner D, Miller GD. Impact of Biotin Supplementation on Human Chorionic Gonadotropin Immunoassays Utilizing Biotin-Streptavidin Binding Methods in Urine. Clin Chem. 2023 Jul 5;69(7):754-762. doi: 10.1093/clinchem/hvad060.

  PMID: 37253044 DERIVED

MeSH Terms

Interventions

Chorionic Gonadotropin; Ovidrel; Biotin; Capsules

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Andre Crouch, MD

  Sports Medicine Research and Testing Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Every other enrollee
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One cohort receives active drug ovidrel plus biotin supplementation One cohort receives active drug ovidrel plus a placebo

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 11, 2022
• Study Start: October 27, 2022
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)