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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Scott Liening, University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01408498
First received: August 2, 2011
Last updated: October 12, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Testosterone's Effects on Threat Perception/Response
Drug: Testosterone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Study on the Effects of Exogenous Testosterone on Threat Perception and Behavioral Avoidance

Resource links provided by NLM:


Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Behavioral response [ Time Frame: 16 hours post testosterone administration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 120
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Placebo Control
Control group who will not receive exogenous testosterone administration. Will act as a comparison group to the testosterone group.
Experimental: Testosterone administration group
Experimental group that will receive a single 10 g dose of 1% testosterone topical gel.
Drug: Testosterone
Topical administration of testosterone gel. Participants receive a one-time, single dose of 10 g of 1% testosterone gel.
Other Name: AngroGel

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).

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408498

Locations
United States, Texas
Seay Building
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Investigators
Principal Investigator: Scott H Liening, B.A. University of Texas at Austin
  More Information

Additional Information:
No publications provided

Responsible Party: Scott Liening, Graduate Student, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01408498     History of Changes
Other Study ID Numbers: SHL-Diss-1
Study First Received: August 2, 2011
Last Updated: October 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas at Austin:
Testosterone
Social psychology
Human behavior

Additional relevant MeSH terms:
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014