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Effects of Fast Acting Testosterone Nasal Spray on Anxiety

Effects of Fast Acting Testosterone Nasal Spray on Anxiety

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02361190
Enrollment
96
Registered
2015-02-11
Start date
2015-02-28
Completion date
2016-05-31
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

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.

Interventions

DRUGTestosterone

Administration of 1ml aqueous nasal spray containing 7mg testosterone propionate

DRUGPlacebo

Administration of 1ml aqueous saline spray

Sponsors

University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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 -

Design outcomes

Primary

MeasureTime frameDescription
Magnitude of behavioral approach30 minutesSubjects 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026