The Influence of Testosterone on Experimental Pain Perception

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05781685
• Other study ID #: 1100595-3
• Status: Completed
• Phase: Early Phase 1
• Start date: October 1, 2017
• Est. completion date: July 17, 2018

Study information

• Verified date: March 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Testosterone
Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.

Other:
• Placebo Syrup
Oil-based sublingual product.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	American Psychological Association (APA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes Testosterone levels	The measured testosterone levels in the participants before and after receiving the intervention	Prior to Intervention (Baseline), 15 minutes Post Intervention
Secondary	Changes Estradiol levels	The measured estradiol levels in the participants before and after receiving the intervention.	Prior to Intervention (Baseline), 15 minutes Post Intervention
Secondary	Changes Progesterone levels	he measured progesterone levels in the participants before and after receiving the intervention.	Prior to Intervention (Baseline), 15 minutes Post Intervention