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

NCT01292785 | Completed DMC

• 1 other identifier: P23021FWF
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Psychological Questionaires

  at baseline, 1 and 4 months after treatment start

Study Arms (2)

Transsexual

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

Drug: Hormones

Healthy control subjects

receiving no hormonal therapy

Interventions

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.

Transsexual

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Transsexuals urging sex reassignment in a clinical setting will be enrolled at the Unit for Gender Identity Disorder at the General Hospital in Vienna. 20 female-to-male (FtM) and 20 male-to-female (MtF) transsexuals will be asked to undergo this fMRI, MRI, DTI and resting-state functional connectivity study. Transsexual subjects are aged between 18 and 50 years old and free from hormone-treatment at baseline. 40 healthy control subjects, matched for age, sex and sexual orientation to transsexual subjects will be recruited.

You may qualify if:

• 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

You may not qualify if:

• severe neurological or internal diseases
• 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.
• general health based on history, physical examination, ECG, laboratory screening, SCID
• willingness and competence to sign the informed consent form
• severe diseases
• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Links

• Related Info

MeSH Terms

Conditions

Gender Dysphoria

Interventions

Hormones

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Rupert R Lanzenberger, A/Prof. MD

  Department of Psychiatry and Psychotherapy, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A/Prof. PD Dr.

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 10, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

AU (1)