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| Name | Class |
|---|---|
| American Psychological Association (APA) | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone | Experimental | Sublingual testosterone |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Period of Intervention (Day 1) |
| |||||||||||||
| Second Period of Intervention (Day 4) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo, Testosterone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | Seconds | 4 hours After Administration |
|
From baseline approximately up to 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Testosterone | Sublingual testosterone Testosterone: Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chance Ryan Strenth | UT Southwestern Medical Center | 337-274-7647 | chance.strenth@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 26, 2017 | Mar 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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The investigational drug pharmacy providing the sublingual testosterone masked the drugs. Neither the participants nor the investigators knew who was receiving testosterone.
| Placebo Syrup | Other | Oil-based sublingual product. |
|
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 |
| NOT COMPLETED |
|
Placebo First: Placebo Syrup: Oil-based sublingual product. Second: Testosterone: Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Changes Testosterone Levels | The measured testosterone levels in the participants before and after receiving the intervention | Posted | Mean | Standard Deviation | pg/ml | Prior to Intervention (Baseline), 15 minutes Post Intervention |
|
|
|
| Secondary | Changes Estradiol Levels | The measured estradiol levels in the participants before and after receiving the intervention. | Posted | Mean | Standard Deviation | pg/ml | Prior to Intervention (Baseline), 15 minutes Post Intervention |
|
|
|
| Secondary | Changes Progesterone Levels | he measured progesterone levels in the participants before and after receiving the intervention. | Posted | Mean | Standard Deviation | pg/ml | Prior to Intervention (Baseline), 15 minutes Post Intervention |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | Placebo Placebo Syrup: Oil-based sublingual product. | 0 | 20 | 0 | 20 | 0 | 20 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |