Completed

NCT Number: NCT01408498

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

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.

Completed

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Key information

Conditions

Testosterone's Effects on Threat Perception/Response

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Seay Building

Austin, Texas, 78712, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone

Drug

Topical administration of testosterone gel. Participants receive a one-time, single dose of 10 g of 1% testosterone gel.

Other names: AngroGel

Primary outcomes

Behavioral response

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Aug 3, 2011
Registry last updated: Oct 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.