Early mental response to hormonal treatment in transgender me

Phase 1

• Conditions: Transsexualism; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2019-004349-34-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-18
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 50

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the level of transgender congruence in transmen with testosterone treatment to placebo treatment;Secondary Objective: To compare fast mental effects of testosterone treatment in transmen to placebo;Primary end point(s): Transgender Congruence scale scoring after 6 weeks of treatment;Timepoint(s) of evaluation of this end point: 6 weeks after one single dose of 1000mg Nebido or Placebo

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Score in Rosenberg Self-esteem Scale, Perth emotional reactivity scale, The brief aggression questionnaire, sexual desire inventory and MADRS-S;Timepoint(s) of evaluation of this end point: 6 weeks after one single dose of 1000mg Nebido or Placebo