Effects of Fast Acting Testosterone Nasal Spray on Anxiety
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable anxiety
Started Feb 2015
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedApril 28, 2021
April 1, 2021
1.2 years
November 20, 2014
April 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
30 minutes
Study Arms (2)
Placebo nasal spray
PLACEBO COMPARATORSubjects will inhale approximately 40ml aqueous solution via intranasal route
Testosterone nasal spray
EXPERIMENTALSubjects will inhale approximately 40ml aqueous, testosterone-containing solution via intranasal route
Interventions
Administration of 1ml aqueous nasal spray containing 7mg testosterone propionate
Eligibility Criteria
You may qualify if:
- Male, 18 years of age or older
You may not qualify if:
- 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
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas at Austin Department of Psychology
Austin, Texas, 78712, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert A Josephs, Phd
University of Texas at Austin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 20, 2014
First Posted
February 11, 2015
Study Start
February 1, 2015
Primary Completion
April 1, 2016
Study Completion
May 1, 2016
Last Updated
April 28, 2021
Record last verified: 2021-04