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
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Condition or disease | Intervention/treatment |
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Gender Identity Disorder | Drug: Hormones |
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 |
Group/Cohort | Intervention/treatment |
---|---|
Transsexual
Female-to-Male and Male-to-Female Transsexuals receiving hormonal therapy
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Drug: Hormones
FtM will receive
MtF will receive
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Healthy control subjects
receiving no hormonal therapy
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- 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
- 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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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | 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.
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

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
Austria | |
Department of Psychiatry and Psychotherapy, Medical University of Vienna | |
Vienna, Austria, 1090 |
Principal Investigator: | Rupert R Lanzenberger, A/Prof. MD | Department of Psychiatry and Psychotherapy, Medical University of Vienna |
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 |
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