The Influence of Testosterone on Experimental Pain Perception

Early Phase 1

Completed

• Conditions: Acute Pain
• Interventions: Drug: Testosterone; Other: Placebo Syrup

• Registration Number: NCT05781685
• Lead Sponsor: University of New Mexico

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Primary Completion: 2018-07-17
• Study Completion: 2018-07-17
• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-23
• Results First Submitted: 2023-03-31
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Results First Posted: 2024-08-05
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Testosterone	Placebo Syrup	Sublingual testosterone
Placebo	Placebo Syrup	Placebo
Testosterone	Testosterone	Sublingual testosterone
Placebo	Testosterone	Placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes Progesterone Levels	Prior to Intervention (Baseline), 15 minutes Post Intervention	he measured progesterone levels in the participants before and after receiving the intervention.
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.

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States