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

This study is currently recruiting participants.
Verified January 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01292785
First received: February 9, 2011
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Gender Identity Disorder
 Drug: Hormones

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • BOLD response to experimental fMRI paradigms [ Time Frame: at baseline, 1 and 4 months after treatment start ] [ Designated as safety issue: No ]
    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:
  • Psychological Questionaires [ Time Frame: at baseline, 1 and 4 months after treatment start ] [ Designated as safety issue: No ]
    Psychological questionaires measuring different aspects of emotion and cognitive processing are used to infer effects of hormonal therapy on these measures


Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Transsexual
Female-to-Male and Male-to-Female Transsexuals receiving hormonal therapy
 Drug: Hormones

FtM will receive

  • 1000mg testosterone undecanoat 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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292785

Locations
Austria
Department of Psychiatry and Psychotherapy, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Rupert Lanzenberger, A/Prof.     +43 40400 ext 3825     rupert.lanzenberger@meduniwien.ac.at    
Principal Investigator: Rupert Lanzenberger, A/Prof. MD            
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Rupert R Lanzenberger, A/Prof. MD Department of Psychiatry and Psychotherapy, Medical University of Vienna
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Rupert Lanzenberger, A/Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01292785     History of Changes
Other Study ID Numbers: P23021FWF
Study First Received: February 9, 2011
Last Updated: January 24, 2013
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013