State of Hormones Impact Nociceptive Expression

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05787470
Status
Recruiting
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Conditions

  • Gender Identity
  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Quantative sensory testing — BEHAVIORAL
    All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
  • Blood Draw — DIAGNOSTIC_TEST
    Sample of blood will be taken.

Study Details

The Investigators have recently published on differences in pain sensitivity measures between cis and trans individuals in the local area. The investigators observed the anticipated differences in pain sensitivity between CM and CW (CW \> CM), but found that the TW were phenotypically similar to CW in all measures. However, the investigators did not assess hormone level, nor did the investigators recruit TM participants. Here, with the assistance of two local community group stakeholders the investigators will recruit the following groups: CM, CW, TM+T (currently taking exogenous testosterone), TW+E (exogenous estradiol), TM, and TW (n=20/group). The investigators will use quantitative sensory testing to assess sensitivity to cold, pressure, and heat via standardized protocols. Blood samples will be taken for assessment of stress and reproductive hormone levels, immune cell populations and stimulated cytokine release. Finally, questionnaires will measure pain state, quality of life (QOL), voice QOL, body image, appearance, self-reported health, masculinity/femininity, community connectedness, gender role, sleep, depression, social support, adverse childhood experiences and stigma.

Key Dates

Start date
Mar 1, 2023
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Cis Man
    Person assigned male at birth and whose gender identity is man.
  • Arm: Cis Woman
    Person assigned female at birth and whose gender identity is woman.
  • Arm: Transgender Man
    Person assigned female at birth and whose gender identity is man.
  • Arm: Transgender Woman
    Person assigned male at birth and whose gender identity is woman.
  • Arm: Transgender Man plus Testosterone
    Person assigned female at birth and whose gender identity is man and are currently on testosterone replacement.
  • Arm: Transgender Woman plus Estrogen
    Person assigned male at birth and whose gender identity is woman and are currently on estrogen replacement.

Primary Outcome Measure

Experimental Heat Pain Thresholds [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Tammie Quinn, BA
[email protected]
205-934-8743

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By research site
University of Alabama at Birmingham· Birmingham, AL

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