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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

Study Description
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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.

Condition or disease Intervention/treatment
Gender Identity Disorder Drug: Hormones

Study Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Study Start Date : January 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Groups and Cohorts
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Group/Cohort Intervention/treatment
Transsexual
Female-to-Male and Male-to-Female Transsexuals receiving hormonal therapy
 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.
Healthy control subjects
receiving no hormonal therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292785


Locations
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Austria
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Rupert R Lanzenberger, A/Prof. MD Department of Psychiatry and Psychotherapy, Medical University of Vienna
More Information
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Additional Information:

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Responsible Party: Rupert Lanzenberger, A/Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01292785    
Other Study ID Numbers: P23021FWF
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs