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Effects of Fast Acting Testosterone Nasal Spray on Anxiety

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Testosterone
Placebo
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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 -

Sites / Locations

  • University of Texas at Austin Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo nasal spray

Testosterone nasal spray

Arm Description

Subjects will inhale approximately 40ml aqueous solution via intranasal route

Subjects will inhale approximately 40ml aqueous, testosterone-containing solution via intranasal route

Outcomes

Primary Outcome Measures

Magnitude of behavioral approach
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

Secondary Outcome Measures

Full Information

First Posted
November 20, 2014
Last Updated
April 26, 2021
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT02361190
Brief Title
Effects of Fast Acting Testosterone Nasal Spray on Anxiety
Official Title
Effects of Fast Acting Testosterone Nasal Spray on Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo nasal spray
Arm Type
Placebo Comparator
Arm Description
Subjects will inhale approximately 40ml aqueous solution via intranasal route
Arm Title
Testosterone nasal spray
Arm Type
Experimental
Arm Description
Subjects will inhale approximately 40ml aqueous, testosterone-containing solution via intranasal route
Intervention Type
Drug
Intervention Name(s)
Testosterone
Other Intervention Name(s)
Testosterone propionate
Intervention Description
Administration of 1ml aqueous nasal spray containing 7mg testosterone propionate
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
saline
Intervention Description
Administration of 1ml aqueous saline spray
Primary Outcome Measure Information:
Title
Magnitude of behavioral approach
Description
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
Time Frame
30 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Josephs, Phd
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Austin Department of Psychology
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Fast Acting Testosterone Nasal Spray on Anxiety

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