Clinical trial NCT03651427: Cross-sex Hormone Therapy and Neuronal Plasticity
Official title: Neuroactive Sex Steroids And Their Influence In Glutamatergic Neurotransmission - Effects in Memory and Cognition in Transgender People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gender Dysphoria
Keywords: Estradiol;
Brain
glutamate
spectroscopy
hypogonadism
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Sel-controlled case series
Primary purpose: TREATMENT

Brief summary: Transgender women (male-to-female) were invited to participate in this study to test the impact of Cross-Sex Hormone Therapy (CSHT) in the brain.

Neuroimaging and cognitive assessment were performed in different time-points to compare the impact of CSHT in the brain.

Detailed description: Sex hormones are known to exert several effect on the brain white matter, cerebral cortex, functional connectivity and neurotransmission. Furthermore, in transgender people, CSHT is know to induce anatomical and functional changes in the brain. However, only a few studies have already been conducted to investigate the effects of sex hormones on the brain accounting for the interference of endogenous gonadal hormones. Also, there is a lack of knowledge about the importance of CSHT after Gender Affirming Surgery (GAS) regarding induced hypogonadism that follows this surgical procedure. Therefore, neuroimaging studies designed to isolate the effect of endogenous gonadal hormones in people with GD urge to be developed.

To fulfil this purpose, transgender women that have already performed GAS and/or were under Gonadotrophin Release Hormone analogues treatment (in order to induce hypogonadism similar to GAS) were invited to interrupt CSHT for at least 30 days to promote sex hormones washout. At the end of the washout, participants performed magnetic resonance imaging, laboratorial analyses for sex hormones and neuro-cognitive assessment. After this first time-point, participants received a new prescription for CSHT containing estradiol (without progesterone) to be used continuously for 60 days, when the same assessments from the end of washout were repeated 60 days after CSHT to compare brain and cognitive longitudinal changes.

At all the time-points, variations in depression scores and anxiety levels were assessed with specific scales.

Eligibility criteria: Inclusion Criteria:

* Transgender women
* Age 18 to 60 years old.

Exclusion Criteria:

* Use of psychostimulant drugs
* Use of Antidepressive, Mood Stabiliser, Anti-psychotic, Benzodiazepines, anti-convulsivants, Anorexigenic
* Endocrinological disease (other than diabetes)
* Arterial Hypertensive Disease of Diabetes Mellitus out of control target
* Neurological disease, including stroke or recent cranial trauma with loss or consciousness
* HIV with low CD4 or high viral charge or symptomatic AIDS
* Neoplasia

Primary outcomes:
measure: Glutamate concentration in the left hippocampus
timeFrame: 90 days
Secondary outcomes:
measure: Cortical Thickness
timeFrame: 90 days
measure: Diffusion track imaging
timeFrame: 90 days
measure: functional connectivity
timeFrame: 90 days
measure: Glutamate concentration in the anterior cingulate cortex and left dorsolateral prefrontal cortex
timeFrame: 90 days
measure: Cognition
timeFrame: 90 days
measure: Operational memory
timeFrame: 90 days
measure: Verbal memory
timeFrame: 90 days
measure: Language (Verbal Fluency)
timeFrame: 90 days
measure: Executive function
timeFrame: 90 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Maria Lobato, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salgado JV, Malloy-Diniz LF, Abrantes SS, Moreira L, Schlottfeldt CG, Guimaraes W, Freitas DM, Oliveira J, Fuentes D. Applicability of the Rey auditory-verbal learning test to an adult sample in Brazil. Braz J Psychiatry. 2011 Sep;33(3):234-7. doi: 10.1590/s1516-44462011005000007.