Back to resultsThe Influence of Testosterone on Experimental Pain Perception
Primary Purpose
Acute Pain
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Testosterone
Placebo Syrup
Sponsored by
About this trial
This is an interventional other trial for Acute Pain focused on measuring testosterone, pain tolerance, estradiol, progesterone
Eligibility Criteria
Inclusion Criteria: Healthy college-aged females that are over the age of 18 and younger than 25 will be used for this study. Exclusion Criteria: The following criteria will exclude a participant from the study: Anyone that has a tree nut allergy. Women that are pregnant or may feel that they may be pregnant or breast-feeding. Anyone taking supplements that may influence their testosterone level. Anyone taking any kind of steroid that may increase their testosterone level. Anyone that smokes tobacco or uses smokeless tobacco. Anyone that reports any condition associated with nerve damage. Anyone that is using hormonal contraceptive. Anyone who was sick or unwell at the time of screening. Each participant completed a Testosterone Pre-Screen form. This form asked each participant individually whether they are taking any drugs or have any conditions that might be exacerbated by testosterone. This form was completed before they signed the consent form and each time they arrived in the lab for an experimental session.
Sites / Locations
- University of New Mexico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Testosterone
Placebo
Arm Description
Sublingual testosterone
Placebo
Outcomes
Primary Outcome Measures
Pain Tolerance
The ischemic discomfort task applied a sphygmomanometer (blood pressure cuff) 5 cm below their elbow. The cuff was inflated to 200 mmHg. Pain tolerance was measured by how long they could tolerate the ischemic discomfort task. However, task was only allowed to last for 6 minutes
Secondary Outcome Measures
Changes Testosterone levels
The measured testosterone levels in the participants before and after receiving the intervention
Changes Estradiol levels
The measured estradiol levels in the participants before and after receiving the intervention.
Changes Progesterone levels
he measured progesterone levels in the participants before and after receiving the intervention.
Full Information
NCT ID
NCT05781685
First Posted
February 23, 2023
Last Updated
March 10, 2023
Sponsor
University of New Mexico
Collaborators
American Psychological Association (APA)
1. Study Identification
Unique Protocol Identification Number
NCT05781685
Brief Title
The Influence of Testosterone on Experimental Pain Perception
Official Title
The Influence of Testosterone on Experimental Pain Perception and Social Psychological Functioning
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
July 17, 2018 (Actual)
Study Completion Date
July 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
American Psychological Association (APA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial examined how the administration of exogenous testosterone would influence pain tolerance and other endogenous steroids (i.e. estradiol and progesterone).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
testosterone, pain tolerance, estradiol, progesterone
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
The investigational drug pharmacy providing the sublingual testosterone masked the drugs. Neither the participants nor the investigators knew who was receiving testosterone.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Testosterone
Arm Type
Experimental
Arm Description
Sublingual testosterone
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Testosterone
Intervention Description
Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.
Intervention Type
Other
Intervention Name(s)
Placebo Syrup
Intervention Description
Oil-based sublingual product.
Primary Outcome Measure Information:
Title
Pain Tolerance
Description
The ischemic discomfort task applied a sphygmomanometer (blood pressure cuff) 5 cm below their elbow. The cuff was inflated to 200 mmHg. Pain tolerance was measured by how long they could tolerate the ischemic discomfort task. However, task was only allowed to last for 6 minutes
Time Frame
4 hours After Administration
Secondary Outcome Measure Information:
Title
Changes Testosterone levels
Description
The measured testosterone levels in the participants before and after receiving the intervention
Time Frame
Prior to Intervention (Baseline), 15 minutes Post Intervention
Title
Changes Estradiol levels
Description
The measured estradiol levels in the participants before and after receiving the intervention.
Time Frame
Prior to Intervention (Baseline), 15 minutes Post Intervention
Title
Changes Progesterone levels
Description
he measured progesterone levels in the participants before and after receiving the intervention.
Time Frame
Prior to Intervention (Baseline), 15 minutes Post Intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy college-aged females that are over the age of 18 and younger than 25 will be used for this study.
Exclusion Criteria:
The following criteria will exclude a participant from the study:
Anyone that has a tree nut allergy.
Women that are pregnant or may feel that they may be pregnant or breast-feeding.
Anyone taking supplements that may influence their testosterone level.
Anyone taking any kind of steroid that may increase their testosterone level.
Anyone that smokes tobacco or uses smokeless tobacco.
Anyone that reports any condition associated with nerve damage.
Anyone that is using hormonal contraceptive.
Anyone who was sick or unwell at the time of screening.
Each participant completed a Testosterone Pre-Screen form. This form asked each participant individually whether they are taking any drugs or have any conditions that might be exacerbated by testosterone. This form was completed before they signed the consent form and each time they arrived in the lab for an experimental session.
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Influence of Testosterone on Experimental Pain Perception
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