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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

No Placebo-Only Group

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.

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.

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.

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I have a history of breast cancer or heart, kidney, or liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in serum concentration of androstenedione

Changes in serum concentration of luteinizing hormone

Changes in serum concentration of testosterone

+1 more

Secondary study objectives

Direct detection of testosterone esters

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met