The Influence of Testosterone on Experimental Pain Perception

Sponsor

University of New Mexico (Other)

Overall Status

Completed

CT.gov ID

NCT05781685

Collaborator

American Psychological Association (APA) (Other)

Enrollment

Location

Arms

9.5

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Pain	Drug: Testosterone Other: Placebo Syrup	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, 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.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 1, 2017

Actual Primary Completion Date :

Jul 17, 2018

Actual Study Completion Date :

Jul 17, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

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.

Placebo Comparator: Placebo

Placebo

Drug: Testosterone

Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.

Other: Placebo Syrup

Oil-based sublingual product.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of New Mexico	Albuquerque	New Mexico	United States	87131

Sponsors and Collaborators

University of New Mexico
American Psychological Association (APA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chance Strenth, Principal Investigator, University of New Mexico

ClinicalTrials.gov Identifier:

NCT05781685

Other Study ID Numbers:

1100595-3

First Posted:

Mar 23, 2023

Last Update Posted:

Mar 23, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Chance Strenth, Principal Investigator, University of New Mexico

Additional relevant MeSH terms:

Acute Pain

Testosterone

Study Results

No Results Posted as of Mar 23, 2023