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

Gender Identity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292785
• Other study ID #: P23021FWF
• Status: Completed
• Phase: N/A
• First received: February 9, 2011
• Last updated: April 8, 2015
• Start date: January 2011
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gender Identity Disorder

Intervention

Drug:
• Hormones
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.

Locations

Country	Name	City	State
Austria	Department of Psychiatry and Psychotherapy, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD response to experimental fMRI paradigms	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	at baseline, 1 and 4 months after treatment start	No
Secondary	Psychological Questionaires	Psychological questionaires measuring different aspects of emotion and cognitive processing are used to infer effects of hormonal therapy on these measures	at baseline, 1 and 4 months after treatment start	No

External Links

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