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Perception of Pain During Gender Affirming Hormone Therapy

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Medical University of Vienna

Status

Enrolling

Conditions

Perception of Pain
Pain Threshold
Transgender Persons
Sex Hormones

Treatments

Diagnostic Test: Patient Health Questionnaire 9
Diagnostic Test: Quantitative Sensory Testing
Diagnostic Test: Hormone concentrations

Study type

Observational

Funder types

Other

Identifiers

NCT07148921
1103/2024

Details and patient eligibility

About

It is known from the literature that women and men differ in their perception of pain. Why this is the case has not been conclusively clarified. Sex hormones could have a significant influence on this. The study team suspects that the classic hormone status of women is responsible for the lower pain threshold compared to men.

People undergoing gender affirming therapy receive biologically opposite-sex hormones in order to adapt their external appearance as well as their voice, emotional life etc. to the desired gender. The aim of this study is to longitudinally record whether the intake of opposite-sex sex hormones leads to a change in pain and perception thresholds in this patient collective. To this end, potential study participants will be informed about the study and asked whether they would like to participate before the start of hormone therapy during their first visit to the transgender outpatient clinic.

If consent is given, a questionnaire on mental health (PHQ 9), a blood sample to determine the hormone status and the first QST (quantitative sensory testing) measurement are then carried out. The second measurement with blood sampling takes place 3-4 weeks after the first measurement. The 3rd and 4th measurements with blood sampling are taken 3 and 6 months respectively after the first measurement. The PHQ 9 is measured again at the time of the last measurement. Study participation ends after a total of 6 months. The blood samples, the PHQ 9 and the QST measurements have no influence on the treatment of the study participants.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 18 years of age
  • Assigned female at birth (AFAB)
  • Diagnosed gender identity disorder/gender dysphoria and planned therapy with testosterone OR
  • ≥ 18 years of age
  • Assigned male at birth (AMAB)
  • Diagnosed gender identity disorder/ gender dysphoria and planned therapy with estradiol

Exclusion criteria

  • Any sex hormone intake during the last 6 months
  • Acute or chronic pain
  • Polyneuropathy
  • Diagnosis of alcohol or drug addiction
  • BMI under 18 or over 35
  • Pregnancy
  • Breastfeeding
  • Pharmacological analgesic therapy within the previous 7 days before each examination
  • History of significant trauma or surgery to the hands with residual neurological deficit or pain.

Trial design

40 participants in 2 patient groups

AFAB Group
Description:
Transgender men and transmasculine individuals
Treatment:
Diagnostic Test: Hormone concentrations
Diagnostic Test: Patient Health Questionnaire 9
Diagnostic Test: Quantitative Sensory Testing
AMAB Group
Description:
Transgender women and transfeminine individuals
Treatment:
Diagnostic Test: Hormone concentrations
Diagnostic Test: Patient Health Questionnaire 9
Diagnostic Test: Quantitative Sensory Testing

Trial contacts and locations

1

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Central trial contact

Aylin Bilir, Dr. med. univ.

Data sourced from clinicaltrials.gov

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