The Influence of Testosterone on Experimental Pain Perception

NCT ID: NCT05781685

Last Updated: 2024-08-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-07-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
The investigational drug pharmacy providing the sublingual testosterone masked the drugs. Neither the participants nor the investigators knew who was receiving testosterone.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Testosterone

Sublingual testosterone

Group Type EXPERIMENTAL

Testosterone

Intervention Type DRUG

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

Placebo Syrup

Intervention Type OTHER

Oil-based sublingual product.

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Testosterone

Intervention Type DRUG

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

Placebo Syrup

Intervention Type OTHER

Oil-based sublingual product.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Testosterone

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

Intervention Type DRUG

Placebo Syrup

Oil-based sublingual product.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American Psychological Association (APA)

OTHER

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chance Strenth

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1100595-3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Testosterone Trials in Older Men
NCT00799617 COMPLETED PHASE3
Impact of Estradiol Addback
NCT01862835 COMPLETED PHASE1
Testosterone Effects on Bone and Frailty
NCT00182871 COMPLETED PHASE4
Subcutaneous Testosterone Project
NCT02229617 COMPLETED PHASE1/PHASE2