Early mental response to hormonal treatment in transgender men - The EMRE Study

Phase 4

Not yet recruiting

• Conditions: Transsexual; Gender dysphoria

• Registration Number: 2024-517052-35-00
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

- Transgender men diagnosed with gender dysphoria, as defined in the ICD-10.
- A wish for full gender-affirming HRT
-Signed informed consent to trial participation consistent with ICH-GCP guidelines and local legislations
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Any concomitant hormonal disease
- Any disability that prevents the patient from fully participating in the study.
- Previous hormonal treatment within three months before the study period (such as HRT using illegally obtained medications).
- Hormonal levels before intervention that differ significantly from physiological levels for assigned sex (suggesting illegal HRT or hormonal disease).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Solna, Sweden

Karolinska University Hospital

🇸🇪Solna, Sweden

Mats Holmberg

Site contact

+46705266365

mats.holmberg.1@ki.se