Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT05787470

Conditions

Pain

Gender Identity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Quantative sensory testing

Blood Draw

Study Details

Brief summary:

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.

Conditions

Pain

Gender Identity

Study ID

NCT05787470

Start date

Mar 1, 2023

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • self-identification as one of the above gender identities
  • understanding of verbal and written English.
  • participants that have been on/off hormone treatment for at least 6 months

Exclusion Criteria:

  • pain in at least 3/7 days/week for the past 3 months
  • HIV positive diagnosis
  • cardiovascular or pulmonary disease
  • regular use of opioid pain medications
  • uncontrolled hypertension (i.e. SBP/DBP of > 150/95)
  • current illness accompanied by fever (body temperature >38 °C)
  • prostatectomy, hysterectomy or oophorectomy
  • hospitalization due to psychiatric illness within the last 6 months.

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Cis Man

Person assigned male at birth and whose gender identity is man.

Cis Woman

Person assigned female at birth and whose gender identity is woman.

Transgender Man

Person assigned female at birth and whose gender identity is man.

Transgender Woman

Person assigned male at birth and whose gender identity is woman.

Transgender Man plus Testosterone

Person assigned female at birth and whose gender identity is man and are currently on testosterone replacement.

Transgender Woman plus Estrogen

Person assigned male at birth and whose gender identity is woman and are currently on estrogen replacement.

Interventions

Quantative sensory testing

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

Sample of blood will be taken.

Primary outcome measure

  • Experimental Heat Pain Thresholds [ Time Frame: Baseline ]
  • Experimental Pressure Pain Thresholds [ Time Frame: Baseline ]
  • Experimental Pain Sensitivity [ Time Frame: Baseline ]
  • Temporal Summation [ Time Frame: Baseline ]
  • Conditioned Pain Modulation [ Time Frame: Baseline ]
  • Sleep quality [ Time Frame: Baseline ]
  • Depression [ Time Frame: Baseline ]
  • Social Support [ Time Frame: Baseline ]
  • Discrimination [ Time Frame: Baseline ]
  • Hormone levels [ Time Frame: Baseline ]
  • Immune cell number [ Time Frame: Baseline ]
  • Immune cell cytokine production [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Tammie Quinn, BA

(205) 934-8743tquinn@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Tammie Quinn, BA

(205) 934-8743tquinn@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jul 2, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-07-02.