Gender Identity Disorder
Conditions
Brief summary
This ultrahigh-field MRI study gives us the unique opportunity to measure changes in brain function and structure induced by long-term opposite-sex steroid hormone administration in transsexual subjects. Our aim is 1. to prove the influence of high-dose, long-term opposite-sex steroid hormone treatment on functional brain response in transsexuals. 2. to investigate the influence of hormone treatment on resting state functional connectivity and brain morphology. 3. to investigate differences between transsexuals and healthy control subjects in brain function and functional connectivity, brain morphology and structural connectivity. In this longitudinal study, transsexuals and healthy control subjects will undergo three 7 Tesla ultrahigh-field MRI scan sessions: 1. baseline (before hormone treatment), 2. after 4 weeks of treatment and 3. after 4 months of treatment.
Interventions
DRUGHormones
FtM will receive * 1000mg testosterone undecanoate every 12 weeks (Nebido® 4ml i.m.), or alternatively 50mg testosterone transdermally (Testogel® 5g-bag per day) and * if menstruation still occurs, additionally either lynestrenol Orgametril® (2-3 tablets/day) or in some cases 0.075mg desogestrel (Cerazette®, 1 tablet/day). MtF will receive * 50mg cyproterone acetate daily (Androcur®) * estradiol 100µg transdermal therapeutic system (TTS) twice a week (Estradot®, Estramon®), especially if subjects age is \> 40 years, or p.o. estradiol 2x2mg (Estrofem®) if subjects age is \< 40 years; alternatively estradiol 0,75-1,5mg (1-2 hubs) transdermally (Estrogel-Gel®) and * 2,5mg alpha-5-reductase-inhibitor every 2nd day (Finasterid Actavis/ Arcana/ Aurobindo®) in case of extensive hair loss.
Sponsors
Medical University of Vienna
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
for transsexuals are: * DSM-IV diagnosis of Gender Identity Disorder (DSM-IV: 302.85, 302.6; ICD-10: F64.9, F64.8) by a structured clinical interview (SCID) * general health based on history, physical examination, ECG, laboratory screening, SCID * willingness and competence to sign the informed consent form
Exclusion criteria
for transsexuals are: * severe neurological or internal diseases * steroid hormone treatment within 2 months prior to inclusion (including birth control pill, phytohormones) * treatment with psychotropic agents such as SSRIs * any implant or stainless steel graft * abnormal values in routine laboratory screening or general physical examination * current substance abuse (determined using drug screening at the screening visit) * pregnancy (determined at screening visit and first MRI scan) * failure to comply with the study protocol or to follow the instructions of the investigating team. Inclusion criteria for healthy controls are: * general health based on history, physical examination, ECG, laboratory screening, SCID * willingness and competence to sign the informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BOLD response to experimental fMRI paradigms | at baseline, 1 and 4 months after treatment start | task-related BOLD (blood oxygen level dependent) responses are evaluated before, and 4 weeks, as well as 4 months of hormonal treatment in transsexual subjects and healthy control subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological Questionaires | at baseline, 1 and 4 months after treatment start | Psychological questionaires measuring different aspects of emotion and cognitive processing are used to infer effects of hormonal therapy on these measures |
Countries
Austria
Outcome results
None listed