Menu
Recruiting NCT07148921

Perception of Pain During Gender Affirming Hormone Therapy

— Observational Transgender Persons Pain Threshold Perception of Pain Sex Hormones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Quantitative Sensory Testing, Patient Health Questionnaire 9, Hormone concentrations.
Who it may be relevant to
Registry conditions: Transgender Persons, Pain Threshold, Perception of Pain, Sex Hormones. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Changes in Pain and Perception Thresholds Due to Gender Affirming Hormone Therapy: a Prospective Exploratory Cohort Study

Overview

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.

Interventions

  • Diagnostic test Quantitative Sensory Testing
    Quantitative sensory testing (QST) is a psychophysical test procedure. With the help of calibrated stimuli and subjective sensory information, the functional state of the somatosensory system of a subject or patient is examined with regard to the expression of clinical signs. The test includes: * Cold detection threshold * Warm detection threshold * Paradoxical heat sensation * Cold pain threshold * Heat pain threshold * Mechanical detection threshold * Mechanical pain threshold * Mechanical p
  • Diagnostic test Patient Health Questionnaire 9
    The Patient Health Questionnaire 9 (PHQ-9), a validated and internationally used health questionnaire, will also be completed twice at the first study day before the sex hormone therapy is initiated and during the last study day in month 6. The questionnaire consists of 9 items on the topic of mental well-being.
  • Diagnostic test Hormone concentrations
    Blood concentrations of the following laboratory parameters will be determined: * Follicle stimulating hormone (FSH) * Luteotropic hormone (LH) * Prolactin (PRL) * Oestradiol (E2) * Sex hormone-binding globulin (SHBG) * Testosterone

Primary outcome measures

  • Cold detection threshold [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Warm detection threshold [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Thermal sensory limen [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Paradoxical heat sensation [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Cold pain threshold [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Heat pain threshold [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Mechanical detection threshold [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Mechanical pain threshold [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Mechanical pain sensitivity [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Dynamic mechanical allodynia [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
Secondary outcome measures (7)
  • Patient Health Questionnaire 9 [Time frame: At the time of enrollment and on the last study day after 6 months.]
  • Hormone concentrations (follicle stimulating hormone) [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Hormone concentrations (luteotropic hormone) [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Hormone concentrations (prolactin) [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Hormone concentrations (oestradiol) [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Hormone concentrations (sex hormone-binding globulin) [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
  • Hormone concentrations (testosterone) [Time frame: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • Mecial University of Vienna — Vienna

Identifiers

NCT: NCT07148921 · 1103/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗