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

NCT01292785 — Completed, 80 participants, Medical University of Vienna

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

Registry	NCT01292785
Status	Completed
Study type	Observational
Enrollment	80 (Actual)
Sponsor	Medical University of Vienna (Other)
Conditions	Gender Identity Disorder
Interventions	Hormones (Drug)
Dates	start 2011-01-01, primary completion 2015-04-01, completion 2015-04-01, first posted 2011-02-10, last updated 2015-04-09
Locations	1 site in Austria

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Transsexual		Drug: Hormones	Female-to-Male and Male-to-Female Transsexuals receiving hormonal therapy
Healthy control subjects			receiving no hormonal therapy

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.

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Department of Psychiatry and Psychotherapy, Medical University of Vienna	Vienna	Austria

+Investigators

Rupert R Lanzenberger, A/Prof. MD, Principal investigator, Department of Psychiatry and Psychotherapy, Medical University of Vienna