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Research of possible effect of sex steriods to the brain.


- candidate number8403
- NTR NumberNTR2493
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-sep-2010
- Secondary IDsNL29233.029.09 METC VUmc
- Public TitleResearch of possible effect of sex steriods to the brain.
- Scientific TitleAbnormal sex hormone exposure of the brain; possible neuroendocrine implications for cognition in adult transsexuals and women with polycystic ovarian syndrome as clinical models.
- ACRONYMNIC-MRI
- hypothesisThe general objectives of this study is to test whether estrogens and androgens in both males and females affect cognitive functions and brain activity.
- Healt Condition(s) or Problem(s) studiedPolycystic ovary syndrome (PCOS), Transsexualism, Functional MRI (fMRI), Cognition, Hormones, Estrogens, Androgens
- Inclusion criteria1. Gender identity disorder according DSM-IV-TR;
2. Polycystic ovary syndrome (PCOS) with clinical or biochemical signs of hyperandrogenism;
3. Eligible for hormone treatment.
- Exclusion criteria1. Persons with insufficient command of the Dutch language;
2. Unadjusted endocrine disorders;
3. Current treatment with sex steroids;
4. Neurological or psychiatric disorders that could lead to deviant test results;
5. Neuropharmacological intervention;
6. Alcohol (>5 units per day) or drug abuse;
7. Contra indications for an MRI scan;
8. Excessive androgen production other than the hypersecretion of androgens from the ovaries;
9. Pregnancy (excluded by a pregnancy test);
10. Current desire to have children.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jun-2010
- planned closingdate1-jan-2013
- Target number of participants80
- InterventionsModel 1: Transsexuals:
After diagnosis, the first phase of sex reassignment is a hormonal therapy to suppress endogenous secondary sex characteristics and to stimulate upcoming of secondary characteristics of the desired other sex. During suppression and after admiration of cross-sex steroids the subjects will be evaluated with a neuropsychological assessment and functional MRI (fMRI).

Model 2: Women with PCOS:
Also the women with PCOS will be examined twice. Before and after three months of anti androgen treatment the subjects will be evaluated with a neuropsychological assessment and an fMRI. The healthy control group will be examined twice without any intervention.
- Primary outcome1. Blood oxygen level dependent (BOLD) response in functional MRI;
2. Test results from the neuropsychological assessments. We will evaluate different cognitive domains with a neuropsychological test battery. The cognitive domains to be evaluated are attention, perceptual speed, memory (verbal and visual) and executive functioning (working memory, fluency and set shifting). We will also present a task to estimate the intelligence level and questionnaires to gather information about the medical history, socio-demographic characteristics and anxiety or depression (SCL '90, HADS).
- Secondary outcome1. Reproductive endocrine serum samples;
2. Blood pressure;
3. Anthropometric measurements;
4. Depression score;
5. Anxiety score.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R.S. Soleman
- CONTACT for SCIENTIFIC QUERIESDr. C.B. Lambalk
- Sponsor/Initiator Stichting wetenschappelijk onderzoek (SWOG), Neuroscience campus Amsterdam (NCA)
- Funding
(Source(s) of Monetary or Material Support)
Hersenstichting Nederland, Nuts/Ohra
- PublicationsN/A
- Brief summaryClinical observations demonstrate convincingly that in men and women sex steroids exert effects on the brain. Studying these sex steroid related functions is important to better understand brain development and potential benefits of interventions and medication. However, in humans these functions have as yet hardly been studied under experimental conditions.
Under normal circumstances in the human both in males and in females a combination of androgen and estrogen exposure is present. This implies that suggested specific effects of male and female sex steroids is not confined to the female sex hormone estrogen in females and the male sex hormone testosterone in males. With regard to functioning of the brain, there is evidence that estrogens exert effects in males and that androgens have effects in females. However, hardly any human studies exist that clearly distinguish estrogen only and androgen only effects on brain function either in the male or the female.
This confusion is because in males a substantial quantity of androgens are converted into estrogens by the enzyme aromatase and in females the ovaries but also the adrenals produce androgens.
With our research paradigms we can contribute to this field of sexsteroid dependant brain function in a unique way.

Objective of the study:
The overall aim of the present work is to evaluate the individual role of androgens and estrogens on brain function in the human with a focus on cognition. Both clinical models give us the opportunity to evaluate cognitive functions and brain activity in unique conditions. By testing cognitive functions and brain activity on different time points with different sex steroid levels, we hope to understand more about the effects of sex steroids on cognitive functioning. Furthermore, we want to study several aspects of brain function when a clear imbalance between these hormones in particular in women is present due to overexposure to androgens.

Study design:
Model 1: Transsexuals:
After diagnosis, the first phase of sex reassignment is a hormonal therapy to suppress endogenous secondary sex characteristics and to stimulate upcoming of secondary characteristics of the desired other sex. During suppression and after admiration of cross-sex steroids the subjects will be evaluated with a neuropsychological assessment and functional MRI (fMRI).
Model 2: Women with PCOS:
Also the women with PCOS will be examined twice. Before and after three months of anti androgen treatment the subjects will be evaluated with a neuropsychological assessment and an fMRI. The healthy control group will be examined twice without any intervention.
- Main changes (audit trail)
- RECORD2-sep-2010 - 16-sep-2010


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