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Effects of Fast Acting Testosterone Nasal Spray on Anxiety

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ClinicalTrials.gov Identifier: NCT02361190
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin

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
Anxiety Drug: Testosterone Drug: Placebo Not Applicable

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  (Clinical Trial)
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 : February 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: 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 Name: Testosterone propionate




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361190


Locations
United States, Texas
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

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02361190     History of Changes
Other Study ID Numbers: 2014-07-0062
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016

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