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

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ClinicalTrials.gov Identifier: NCT01292785
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna

February 9, 2011
February 10, 2011
April 9, 2015
January 2011
April 2015   (Final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT01292785 on ClinicalTrials.gov Archive Site
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
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Effects of Sex Steroid Hormones on Human Brain Function, Structure and Connectivity
Effects of Sex Steroid Hormones on Human Brain Function, Structure and Connectivity: A Longitudinal Study Using 7 Tesla Ultrahigh-field Magnetic Resonance Imaging
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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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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.

Gender Identity Disorder
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.
  • Transsexual
    Female-to-Male and Male-to-Female Transsexuals receiving hormonal therapy
    Intervention: Drug: Hormones
  • Healthy control subjects
    receiving no hormonal therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
Same as current
April 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT01292785
P23021FWF
Yes
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Rupert Lanzenberger, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Rupert R Lanzenberger, A/Prof. MD Department of Psychiatry and Psychotherapy, Medical University of Vienna
Medical University of Vienna
April 2015