Effects of Fast Acting Testosterone Nasal Spray on Anxiety

April 26, 2021 updated by: Robert Josephs, University of Texas at Austin
The proposed study will test the effects of a fast-acting testosterone nasal spray on the fear reactions of young men to two distinct anxiety challenges (social and nonsocial) using a double-blind randomized experimental design.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim 1: Test the hypothesis that men administered testosterone nasal spray will result in lower levels of anxiety (anticipatory and situational) and greater levels of approach behavior in response to two distinct (social and nonsocial) anxiety challenges relative to men administered placebo spray.

Aim 2: Test the hypothesis that anxiety challenge type (social versus nonsocial) will moderate the effects of testosterone administration on subjects' responses to challenge.

Aim 3: Test the hypothesis that rejection sensitivity - heightened sensitivity to evaluative threat - will moderate the effects of drug condition on response to the two anxiety challenge tests.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • University of Texas at Austin Department of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male, 18 years of age or older

Exclusion Criteria:

  • Male breast cancer
  • Obstructive sleep apnea
  • Suspected or diagnosed prostate cancer
  • Male breast cancer
  • Obstructive sleep apnea
  • Diabetes
  • Heart Disease
  • Liver disease (e.g., hepatitis)
  • Kidney disease
  • Thyroid disease
  • Tuberculosis or history if positive TB test
  • Infection or fever in the past 7 days
  • Surgeries within the last 6 weeks
  • Anemia
  • Gastrointestinal disease
  • Respiratory disease (e.g., asthma or chronic bronchitis)
  • Other (Please list)
  • Reynaud's Disease
  • Type 2 diabetes
  • Diagnosed hypersensitivity to cold
  • Warfarin (Coumadin) for thinning blood
  • Insulin or any oral drugs for diabetes
  • Propranolol (Inderal)
  • Oxyphenbutazone
  • Imipramine
  • Any kind of corticosteroid drug
  • Insulin
  • Steroids
  • Statins (i.e.., cholesterol lowering drugs)
  • Sleeping pills
  • Drugs to treat hormone disorders
  • Antibiotics in the past 7 days
  • Gastrointestinal disease
  • Pain Killers -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo nasal spray
Subjects will inhale approximately 40ml aqueous solution via intranasal route
Drug: Placebo
Administration of 1ml aqueous saline spray
Other Names:
  • saline
Experimental: Testosterone nasal spray
Subjects will inhale approximately 40ml aqueous, testosterone-containing solution via intranasal route
Drug: Testosterone
Administration of 1ml aqueous nasal spray containing 7mg testosterone propionate
Other Names:
  • Testosterone propionate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnitude of behavioral approach
Time Frame: 30 minutes
Subjects will be asked to approach a fearful object. Approach will be measured as number of steps (out of 18) the subject completes, with each step bringing the subject closer to the target object
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Investigators

  • Principal Investigator: Robert A Josephs, PhD, University of Texas at Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

February 5, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-07-0062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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