Acute Pain
Conditions
Keywords
testosterone, pain tolerance, estradiol, progesterone
Brief summary
This trial examined how the administration of exogenous testosterone would influence pain tolerance and other endogenous steroids (i.e. estradiol and progesterone).
Interventions
DRUGTestosterone
Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.
OTHERPlacebo Syrup
Oil-based sublingual product.
Sponsors
American Psychological Association (APA)
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
The investigational drug pharmacy providing the sublingual testosterone masked the drugs. Neither the participants nor the investigators knew who was receiving testosterone.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Tolerance | 4 hours After Administration | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes Testosterone Levels | Prior to Intervention (Baseline), 15 minutes Post Intervention | The measured testosterone levels in the participants before and after receiving the intervention |
| Changes Estradiol Levels | Prior to Intervention (Baseline), 15 minutes Post Intervention | The measured estradiol levels in the participants before and after receiving the intervention. |
| Changes Progesterone Levels | Prior to Intervention (Baseline), 15 minutes Post Intervention | he measured progesterone levels in the participants before and after receiving the intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Testosterone, Placebo Sublingual testosterone
First: Testosterone: Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.
Second: Placebo Syrup: Oil-based sublingual product. | 10 |
| Placebo, Testosterone Placebo
First: Placebo Syrup: Oil-based sublingual product.
Second: Testosterone: Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Testosterone, Placebo | Placebo, Testosterone | Total |
|---|---|---|---|
| Age, Continuous | 18.8 Years STANDARD_DEVIATION 0.92 | 18.6 Years STANDARD_DEVIATION 0.97 | 18.7 Years STANDARD_DEVIATION 0.92338 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
Time frame: 4 hours After Administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone | Pain Tolerance | 224.20500 Seconds | Standard Deviation 91.14411 |
| Placebo | Pain Tolerance | 224.92615 Seconds | Standard Deviation 94.080395 |
Secondary
Changes Estradiol Levels
The measured estradiol levels in the participants before and after receiving the intervention.
Time frame: Prior to Intervention (Baseline), 15 minutes Post Intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone | Changes Estradiol Levels | -0.903160000000 pg/ml | Standard Deviation 0.1943390807362 |
| Placebo | Changes Estradiol Levels | 0.1801549999999 pg/ml | Standard Deviation 0.0950549798844 |
Secondary
Changes Progesterone Levels
he measured progesterone levels in the participants before and after receiving the intervention.
Time frame: Prior to Intervention (Baseline), 15 minutes Post Intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone | Changes Progesterone Levels | -423.63719 pg/ml | Standard Deviation 72.274306309941 |
| Placebo | Changes Progesterone Levels | 29.381135 pg/ml | Standard Deviation 59.866738560717 |
Secondary
Changes Testosterone Levels
The measured testosterone levels in the participants before and after receiving the intervention
Time frame: Prior to Intervention (Baseline), 15 minutes Post Intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone | Changes Testosterone Levels | 580.299600 pg/ml | Standard Deviation 45.919951749402 |
| Placebo | Changes Testosterone Levels | 38.3972 pg/ml | Standard Deviation 10.859257363884 |