Hormonal treatment effects on transgender men
Early Mental Response to Hormonal Treatment in Transgender Men - The EMRE Study
This study tests if giving testosterone to transgender men for six weeks can help improve their feelings about their gender and boost their mental health compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05649605 on ClinicalTrials.gov |
What this trial studies
This study investigates whether transgender men's experience of gender incongruence improves within six weeks of receiving testosterone treatment compared to a placebo. It also examines the impact of cross-sex hormone therapy on various psychological factors such as self-esteem, quality of life, and emotional reactivity. Participants will receive either testosterone via intramuscular injection or a placebo, with assessments conducted to evaluate changes in their mental health and overall well-being. The study aims to provide insights into the early effects of hormonal treatment before any physical changes occur.
Who should consider this trial
Good fit: Ideal candidates for this study are adult transgender men diagnosed with transsexualism who are seeking gender-confirming hormonal treatment.
Not a fit: Patients with concurrent hormonal conditions or disabilities that prevent full participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how hormonal treatment affects mental health and quality of life for transgender men.
How similar studies have performed: While there have been studies on hormone therapy in transgender individuals, this specific approach focusing on early mental responses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Well-informed written consent to participate in the study. 2. Transgender man given the ICD-10 diagnosis of transsexualism. 3. A desire for complete gender-confirming hormonal treatment. 4. Approved for Nebido treatment by a clinically responsible Endocrinologist. Exclusion criteria: 1. A concomitant hormonal condition affecting the gonadal axis (e.g. Congenital Adrenal Hyperplasia, Poly Cystic Ovary Syndrome, Complete Androgen Insensitivity Syndrome, Partial Androgen Insensitivity Syndrome, untreated thyroid disease, untreated hypercortisolism, etc.). 2. A disability that prevents the patient from fully participating in the study. 3. Treatment with steroid hormones (androgens, estrogens, progestogens, or continuous treatment with oral corticosteroids within the last three months). 4. Previous use of hormone preparations without a doctor's prescription. 5. Laboratory samples significantly outside the normal reference range. 6. Anamnestic or investigational suspicion of breast cancer or existing or previous liver tumors. 7. Levels of P-ASAT, P-ALAT, or P-GT at the screening time that are\> 2 times the reference range. 8. Hypersensitivity to the active substance or to any of the excipients. 9. Ongoing pregnancy or wishes for a pregnancy in the near future.
Where this trial is running
Stockholm
- Karolinska Universitetssjukhuset, ANOVA — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Mats Holmberg, MD. PhD. — ANOVA Karolinska sjukhuset
- Study coordinator: Mats Holmberg, MD. PhD.
- Email: mats.holmberg.1@ki.se
- Phone: +46705266365
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.