Pain sensitivity during gender‑affirming hormone therapy
Changes in Pain and Perception Thresholds Due to Gender Affirming Hormone Therapy: a Prospective Exploratory Cohort Study
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT07148921 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Vienna, State of Vienna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.