Study on the Effects of Exogenous Testosterone on Threat Perception and Behavioral Avoidance

Study Overview
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Brief Summary
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The study aims to establish a clear causal link between testosterone and threat perception and behavioral responses to threat. Namely, the study focuses whether high levels of testosterone will cause an individual to exhibit increased physiological responses to threat (e.g., increased blood pressure, heart rate, and endocrine responses) and a decreased behavioral response (e.g., ignoring the threat, avoiding the threat, and postponing dealing with the threat). The threat in this study is a social threat involving public speaking, and is an outgrowth of previous research on the avoidance of health threats.

Detailed Description
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Participants in the study will receive either a single dose of 10g 1% testosterone topical gel or placebo the day prior to participating in the study. The day of the study, participants will provide saliva samples throughout the study to track testosterone and cortisol levels. Participants will be asked to complete the Trier Social Stressor Task, which includes having to give a 5 minute speech to a panel of judges. Participants will be given the opportunity to postpone giving their speech to an unspecified date. The study will focus on two types of responses to the threat of public speaking: behavioral and physiological. The behavior of interest will be participants desire to postpone dealing with the threat (it is hypothesized that those in the testosterone administration group will have an increased desire to postpone). The physiological responses include increased levels of cortisol and increased cardiovascular tone (it is hypothesized that the testosterone administration group will show an increased physiological response compared to the placebo group).

Official Title
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Study on the Effects of Exogenous Testosterone on Threat Perception and Behavioral Avoidance

Conditions
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Testosterone's Effects on Threat Perception/Response

Intervention / Treatment
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* Drug: Testosterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male In good health Aged 18-35 Exclusion Criteria: Female Known carcinoma of the breast or prostate Known sensitivity to alcohol or soy products Preexisting cardiac, renal, or hepatic diseases Obesity Chronic lung diseases Cancer Use of anticoagulants Use of insulin or a history of diabetes Use of corticosteroids High levels of physical contact with women or children Preexisting liver problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Placebo Control<br>Control group who will not receive exogenous testosterone administration. Will act as a comparison group to the testosterone group. | |
| Experimental: Testosterone administration group<br>Experimental group that will receive a single 10 g dose of 1% testosterone topical gel. | Drug: Testosterone<br>* Topical administration of testosterone gel. Participants receive a one-time, single dose of 10 g of 1% testosterone gel.<br>* Other names: AngroGel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral response | Participants will be asked to give a public speech, but will be given the opportunity to postpone the speech to a future date. Postponement is considered an avoidance-oriented behavioral response to a perceived social threat. | 16 hours post testosterone administration | 
| Physiological response | Participants will have cortisol and cardiovascular tone tracked during the social threat protocol. Prior to, during, and after being asked, preparing, and giving a public speech, participants' physiological stress markers will be assessed. | 16 hours post testosterone administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Testosterone, Social psychology, Human behavior