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

NCT ID: NCT01292785

Last Updated: 2015-04-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-04-30

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.

Conditions

Gender Identity Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Transsexual

Female-to-Male and Male-to-Female Transsexuals receiving hormonal therapy

Hormones

Intervention Type: 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.

Healthy control subjects

receiving no hormonal therapy

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• general health based on history, physical examination, ECG, laboratory screening, SCID
• willingness and competence to sign the informed consent form

Exclusion Criteria

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Rupert Lanzenberger

A/Prof. PD Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rupert R Lanzenberger, A/Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Locations

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, , Austria

Countries

Austria

Related Links

http://www.meduniwien.ac.at/neuroimaging/

Related Info

Other Identifiers

P23021FWF

Identifier Type: -

Identifier Source: org_study_id