Testosterone's Effects on Threat Perception/ResponseNCT01408498
Study on the Effects of Exogenous Testosterone on Threat Perception and Behavioral Avoidance
A study testing Testosterone in people with Testosterone's Effects on Threat Perception/Response, run by University of Texas at Austin at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Testosterone's Effects on Threat Perception/Response
- What is being tested?
- Testosterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- In good health
- Aged 18-35
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Being tested
- Testosterone
- Keywords
- Testosterone, Social psychology, Human behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Also called AngroGel
Topical administration of testosterone gel. Participants receive a one-time, single dose of 10 g of 1% testosterone gel.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 hours post testosterone administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testosterone's Effects on Threat Perception/ResponseStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Liening, University of Texas at Austin
- Investigators
- Scott H Liening, B.A., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408498
- Sponsor's protocol ID
- SHL-Diss-1
- Status last verified
- Oct 2012
- First submitted
- 2 Aug 2011
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of Exogenous Testosterone on Threat Perception and Behavioral Avoidance
- ClinicalTrials.gov ID
- NCT01408498
- Acronym / sponsor ID
- SHL-Diss-1
- Keywords
- Testosterone, Social psychology, Human behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: TestosteroneExperimental group that will receive a single 10 g dose of 1% testosterone topical gel. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- In good health
- Aged 18-35
Key exclusion criteria (12 listed)
- Female
- Known carcinoma of the breast or prostate
- Known sensitivity to alcohol or soy products
- Preexisting cardiac, renal, or hepatic diseases
- Obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestosteroneAlso: AngroGelTopical administration of testosterone gel. Participants receive a one-time, single dose of 10 g of 1% testosterone gel. | Drug | Testosterone administration group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott H Liening, B.A. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testosterone in people with Testosterone's Effects on Threat Perception/Response, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral response (time frame: 16 hours post testosterone administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2012.