E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Transsexualism |
Transsexualism |
|
E.1.1.1 | Medical condition in easily understood language |
Transsexualism |
Transsexualism |
|
E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Psychological processes [F02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the level of transgender congruence in transmen with testosterone treatment to placebo treatment |
Att jämföra nivån av könsinkongruens hos transmän med testosteronbehandling ned placebobehandling |
|
E.2.2 | Secondary objectives of the trial |
To compare fast mental effects of testosterone treatment in transmen to placebo |
Att jämföra de snabba mentala effekterna av testosteronbehandling hos transmän jämfört med placebobehandling |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
Transmän med en transsexualismdiagnos enligt ICD-10
Ett önskemål om full könskonträr hormonbehandling
Signerad informed consent till deltagande |
|
E.4 | Principal 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).
|
Annan hormonell sjukdom
Annan avvikelse som förhindrar deltagande i studien
Tidigare hormonbehandling inom tre månader innan studiestart
Hormonnivåer innan studiestart som avviker kraftigt från fysiologiska nivåer.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Transgender Congruence scale scoring after 6 weeks of treatment |
Transgender Congruence scale poäng efter 6 veckors behandling |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 weeks after one single dose of 1000mg Nebido or Placebo |
6 veckor efter en singeldos av 1000 mg Nebido eller placebo |
|
E.5.2 | Secondary end point(s) |
Score in Rosenberg Self-esteem Scale, Perth emotional reactivity scale, The brief aggression questionnaire, sexual desire inventory and MADRS-S |
Poäng i Rosenberg Self-esteem Scale, Perth emotional reactivity scale, The brief aggression questionnaire, sexual desire inventory och MADRS-S |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 weeks after one single dose of 1000mg Nebido or Placebo |
6 veckor efter en injektion av 1000mg Nebido eller Placebo |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Sista besöket av den sista deltagaren |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |