Trial Outcomes & Findings for The Influence of Testosterone on Experimental Pain Perception (NCT NCT05781685)

Results Overview

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

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

20 participants

Primary outcome timeframe

4 hours After Administration

Results posted on

2024-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
First Period of Intervention (Day 1) STARTED	10	10
First Period of Intervention (Day 1) COMPLETED	10	10
First Period of Intervention (Day 1) NOT COMPLETED	0	0
Second Period of Intervention (Day 4) STARTED	10	10
Second Period of Intervention (Day 4) COMPLETED	10	10
Second Period of Intervention (Day 4) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testosterone, Placebo n=10 Participants 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.	Placebo, Testosterone n=10 Participants Placebo First: Placebo Syrup: Oil-based sublingual product. Second: Testosterone: Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.	Total n=20 Participants Total of all reporting groups
Age, Continuous	18.8 Years STANDARD_DEVIATION .92 • n=10 Participants	18.6 Years STANDARD_DEVIATION .97 • n=10 Participants	18.7 Years STANDARD_DEVIATION .92338 • n=20 Participants
Sex: Female, Male Female	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Testosterone n=20 Participants Sublingual testosterone Testosterone: Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.	Placebo n=20 Participants Placebo Placebo Syrup: Oil-based sublingual product.
Pain Tolerance	224.20500 Seconds Standard Deviation 91.144110	224.92615 Seconds Standard Deviation 94.080395

SECONDARY outcome

Timeframe: Prior to Intervention (Baseline), 15 minutes Post Intervention

The measured testosterone levels in the participants before and after receiving the intervention

Outcome measures

Outcome measures
Measure	Testosterone n=20 Participants Sublingual testosterone Testosterone: Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.	Placebo n=20 Participants Placebo Placebo Syrup: Oil-based sublingual product.
Changes Testosterone Levels	580.299600 pg/ml Standard Deviation 45.919951749402	38.3972 pg/ml Standard Deviation 10.859257363884

SECONDARY outcome

Timeframe: Prior to Intervention (Baseline), 15 minutes Post Intervention

The measured estradiol levels in the participants before and after receiving the intervention.

Outcome measures

Outcome measures
Measure	Testosterone n=20 Participants Sublingual testosterone Testosterone: Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.	Placebo n=20 Participants Placebo Placebo Syrup: Oil-based sublingual product.
Changes Estradiol Levels	-0.903160000000 pg/ml Standard Deviation 0.1943390807362	0.1801549999999 pg/ml Standard Deviation 0.0950549798844

SECONDARY outcome

Timeframe: Prior to Intervention (Baseline), 15 minutes Post Intervention

he measured progesterone levels in the participants before and after receiving the intervention.

Outcome measures

Outcome measures
Measure	Testosterone n=20 Participants Sublingual testosterone Testosterone: Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.	Placebo n=20 Participants Placebo Placebo Syrup: Oil-based sublingual product.
Changes Progesterone Levels	-423.63719 pg/ml Standard Deviation 72.274306309941	29.381135 pg/ml Standard Deviation 59.866738560717

Adverse Events

Testosterone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chance Ryan Strenth

UT Southwestern Medical Center

Phone: 337-274-7647

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place