Effects of Sex Steroid Hormones on Human Brain Function, Structure and Connectivity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gender Identity Disorder Gender Dysphoria Mental Disorders Sexual Dysfunctions, Psychological

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

for healthy controls are:

severe diseases
any implant or stainless steel graft
steroid hormone treatment within 2 months prior to inclusion (including birth control pill, phytohormones)
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

Treatment and study plan

Hormones

Drug

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.

Primary outcomes

BOLD response to experimental fMRI paradigms

Time frame: 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 outcomes

Psychological Questionaires

Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Effects of Sex Steroid Hormones on Human Brain Function, Structure and Connectivity: A Longitudinal Study Using 7 Tesla Ultrahigh-field Magnetic Resonance Imaging

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Feb 10, 2011
Registry last updated: Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed