Transsexualism
Conditions
Interventions
Trade Name: Nebido
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Sweden
Contacts
Public ContactDavid Nathanson
Karolinska University Hospital
Outcome results
None listed