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

NCT01408498 | Completed DMC

• 1 other identifier: SHL-Diss-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Testosterone's Effects on Threat Perception/Response

Keywords

Testosterone; Social psychology; Human behavior

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Placebo Control

NO INTERVENTION

Control group who will not receive exogenous testosterone administration. Will act as a comparison group to the testosterone group.

Testosterone administration group

EXPERIMENTAL

Experimental group that will receive a single 10 g dose of 1% testosterone topical gel.

Drug: Testosterone

Interventions

Testosterone DRUG

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

Also known as: AngroGel

Testosterone administration group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• In good health
• Aged 18-35

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Seay Building

Austin, Texas, 78712, United States

Location

MeSH Terms

Interventions

Testosterone

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Scott H Liening, B.A.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 3, 2011
• Study Start: January 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 16, 2012

Record last verified: 2012-10

Locations

US (1)