The Influence of Testosterone on Experimental Pain Perception

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

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

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Testosterone; Other: Placebo Syrup

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: American Psychological Association (APA)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): July 17, 2018
• Study Completion (Actual): July 17, 2018

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: estradiol; progesterone; testosterone; pain tolerance
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: 1100595-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No