The Influence of Testosterone on Experimental Pain Perception

Study Overview
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Brief Summary
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This trial examined how the administration of exogenous testosterone would influence pain tolerance and other endogenous steroids (i.e. estradiol and progesterone).

Official Title
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The Influence of Testosterone on Experimental Pain Perception and Social Psychological Functioning

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Testosterone
* Other: Placebo Syrup


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testosterone<br>Sublingual testosterone | Drug: Testosterone<br>* Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.<br>Other: Placebo Syrup<br>* Oil-based sublingual product.<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Testosterone<br>* Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.<br>Other: Placebo Syrup<br>* Oil-based sublingual product.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 hours After Administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes Testosterone levels | The measured testosterone levels in the participants before and after receiving the intervention | Prior to Intervention (Baseline), 15 minutes Post Intervention | 
| Changes Estradiol levels | The measured estradiol levels in the participants before and after receiving the intervention. | Prior to Intervention (Baseline), 15 minutes Post Intervention | 
| Changes Progesterone levels | he measured progesterone levels in the participants before and after receiving the intervention. | Prior to Intervention (Baseline), 15 minutes Post Intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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testosterone, pain tolerance, estradiol, progesterone