Can Biotin Supplementation be Used to Mask hCG Abuse?

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sports Medicine Research and Testing Laboratory
• Treatments: Biotin; Chorionic Gonadotropin

Criteria

Inclusion Criteria:

• Participants must be healthy males aged 18 or older

• Participants must be actively exercising individuals

Exclusion Criteria:

• 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