NCT05781685

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Oct 2017

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2018

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 5, 2024

Completed
Last Updated

August 5, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

February 23, 2023

Results QC Date

March 31, 2023

Last Update Submit

July 10, 2024

Conditions

Acute Pain

Keywords

testosteronepain toleranceestradiolprogesterone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes Testosterone Levels

    Prior to Intervention (Baseline), 15 minutes Post Intervention

  • Changes Estradiol Levels

    Prior to Intervention (Baseline), 15 minutes Post Intervention

  • Changes Progesterone Levels

    Prior to Intervention (Baseline), 15 minutes Post Intervention

Study Arms (2)

Testosterone

EXPERIMENTAL

Sublingual testosterone

Drug: TestosteroneOther: Placebo Syrup

Placebo

PLACEBO COMPARATOR

Placebo

Drug: TestosteroneOther: Placebo Syrup

Interventions

TestosteroneDRUG

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

PlaceboTestosterone
Placebo SyrupOTHER

Oil-based sublingual product.

PlaceboTestosterone

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy college-aged females that are over the age of 18 and younger than 25 will be used for this study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Testosterone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Chance Ryan Strenth
Organization
UT Southwestern Medical Center
chance.strenth@utsouthwestern.edu
337-274-7647

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The investigational drug pharmacy providing the sublingual testosterone masked the drugs. Neither the participants nor the investigators knew who was receiving testosterone.
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 23, 2023

Study Start

October 1, 2017

Primary Completion

July 17, 2018

Study Completion

July 17, 2018

Last Updated

August 5, 2024

Results First Posted

August 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)