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Hormone Therapy

Testosterone Administration Methods for Healthy Subjects (T esters Trial)

Phase < 1
Waitlist Available
Research Sponsored by Sports Medicine Research and Testing Laboratory
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy male adults, aged 18-60 years
Be between 18 and 65 years old
Must not have
Individuals that are diabetic or are currently taking a diabetic medication
Individuals with severe acne
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

"This trial found that many athletes around the world, including those in professional sports leagues in the United States, are using testosterone inappropriately."

Who is the study for?
This trial is for healthy male adults between the ages of 18 and 60. It's not suitable for those with high blood cell counts, recent blood donors, athletes in anti-doping pools who won't give samples, people with severe acne or diabetes, non-exercisers at heart attack risk, or anyone with a history of breast cancer or heart, kidney, or liver diseases.Check my eligibility
What is being tested?
The study compares different ways to detect testosterone use by testing three methods: injections, gel application on the skin, and oral intake. The goal is to identify which detection method works best for each administration route in healthy men.See study design
What are the potential side effects?
Potential side effects from testosterone use can include mood swings, increased red blood cell count leading to thickened blood (polycythemia), skin reactions at the application site if using gel form like itching or rash; and possible increase in acne.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy man aged between 18 and 60.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am diabetic or currently taking medication for diabetes.
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I have severe acne.
Select...
I have a history of breast cancer or heart, kidney, or liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in serum concentration of androstenedione
Changes in serum concentration of luteinizing hormone
Changes in serum concentration of testosterone
+1 more
Secondary outcome measures
Direct detection of testosterone esters

Trial Design

2Treatment groups
Active Control
Group I: Testosterone group oneActive Control2 Interventions
The participant will receive a single injection of one of three types of testosterone in phase one. In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow.
Group II: Testosterone group twoActive Control2 Interventions
The participant will receive a single injection of one of three types of testosterone in phase one. In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow.

Find a Location

Who is running the clinical trial?

Sports Medicine Research and Testing LaboratoryLead Sponsor
5 Previous Clinical Trials
91 Total Patients Enrolled
Geoff Miller, PhDStudy DirectorSports Medicine Research and Testing Laboratory
~0 spots leftby Aug 2024