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Effects of Fast Acting Testosterone Nasal Spray on Anxiety

Sponsor
University of Texas at Austin (Other)
Overall Status
Completed
CT.gov ID
NCT02361190
Collaborator
(none)
96
Enrollment
1
Location
2
Arms
14.9
Duration (Months)
6.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effects of Fast Acting Testosterone Nasal Spray on Anxiety
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Magnitude of behavioral approach [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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 -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas at Austin Department of Psychology Austin Texas United States 78712

    Sponsors and Collaborators

    • University of Texas at Austin

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Josephs, Professor, University of Texas at Austin
    ClinicalTrials.gov Identifier:
    NCT02361190
    Other Study ID Numbers:
    • 2014-07-0062
    First Posted:
    Feb 11, 2015
    Last Update Posted:
    Apr 28, 2021
    Last Verified:
    Apr 1, 2021
    Additional relevant MeSH terms:
    Anxiety Disorders
    Methyltestosterone
    Testosterone
    Testosterone undecanoate
    Testosterone enanthate
    Testosterone 17 beta-cypionate

    Study Results

    No Results Posted as of Apr 28, 2021