Pain sensitivity during gender‑affirming hormone therapy
Official title: Changes in Pain and Perception Thresholds Due to Gender Affirming Hormone Therapy: a Prospective Exploratory Cohort Study
Run by Medical University of Vienna · NCT07148921 · Data updated 2026-11-12
This project will see if starting gender‑affirming hormones changes pain and perception thresholds in transgender adults beginning cross‑sex hormone therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | December 2025 |
| Study ends | March 2026 |
| Registry record updated | August 29, 2025 |
| Trial ID | NCT07148921 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with diagnosed gender dysphoria who are planning to start cross‑sex hormone therapy (AFAB starting testosterone or AMAB starting estradiol), with no sex hormone use in the prior 6 months and no contraindicating pain or neurological conditions.
✕Probably not a fit
People with recent sex hormone use, existing acute or chronic pain, polyneuropathy, active substance addiction, BMI <18 or >35, pregnancy or breastfeeding, or recent analgesic use are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults presenting for gender‑affirming hormone therapy are tested before starting hormones and followed over time to track changes in pain perception. Baseline and follow‑up visits include quantitative sensory testing, PHQ‑9 mental health questionnaires, and measurement of sex hormone concentrations. Participants are excluded if they have recent hormone use, acute or chronic pain conditions, neuropathy, substance addiction, extreme BMI, pregnancy, or recent analgesic use. The single‑center study is conducted at the Medical University of Vienna and compares within‑person changes after initiating opposite‑sex hormones.
Why it matters
Potential benefit: If successful, the findings could clarify whether cross‑sex hormones alter pain thresholds and help tailor pain counseling and management for transgender patients.
How similar studies have gone: Prior research documents sex differences in pain and links to sex hormones, but longitudinal evaluations during gender‑affirming hormone therapy are limited, so this approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Mecial University of Vienna
Vienna, State of Vienna, Austria Recruiting
Study contacts
- Principal investigator: Oliver Kimberger, Prof. — Medical University of Vienna, Dept. of Anaesthesiology, Critical Care and Pain Medicine
- Study coordinator: Aylin Bilir, Dr. med. univ.
- Email: aylin.bilir@meduniwien.ac.at
- Phone: +43 (0)1 40400-41020
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.