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

Not Applicable

Completed

• Conditions: Testosterone's Effects on Threat Perception/Response
• Interventions: Drug: Testosterone

• Registration Number: NCT01408498
• Lead Sponsor: University of Texas at Austin

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Study Start: 2012-01
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-12
• Last Update Posted: 2012-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone administration group	Testosterone	Experimental group that will receive a single 10 g dose of 1% testosterone topical gel.

Primary Outcome Measures

Name	Time	Method
Behavioral response	16 hours post testosterone administration	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.
Physiological response	16 hours post testosterone administration	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.

Trial Locations

Locations (1)

Seay Building; 🇺🇸 Austin, Texas, United States