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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transgender Women | Experimental | Transgender women who already completed GAS or that agreed to start gonadotropin release hormone analogue to suppress endogenous sex hormones. If the participants were using CSHT in the moment of the study assignment, they were asked to stop hormones for 30 days to evaluate the impact of hypogonadism in the brain. After this first assessment, they received prescriptions for Estradiol (equine conjugated oestrogen, or estradiol valerate, or topic 17-beta estradiol formulations) for 60 days, and the impact of CSHT was evaluated again to compare to washout condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol | Drug | Induced hypogonadism and re-institution of CSHT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glutamate concentration in the left hippocampus | Proton Spectroscopy - magnetic resonance imaging; Glutamate concentration in the left hippocampus will be primarily correlated to working memory scores. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cortical Thickness | Anatomical magnetic resonance imaging | 90 days |
| Diffusion track imaging | Micro-Structural magnetic resonance imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maiko Schneider, MD | Contact | 5551997722606 | maikoschneider@hcpa.edu.br | |
| Fernanda Rohrsetzer | Contact | 51999614503 | fcunegatto@hcpa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Maria Lobato, Dr | Hospital de ClÃnicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21971775 | Result | 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. |
| Label | URL |
|---|---|
| This references is related to the "verbal memory" evaluation, described in the outcomes. | View source |
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| ID | Term |
|---|---|
| D000068116 | Gender Dysphoria |
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Sel-controlled case series
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| 90 days |
| functional connectivity | functional magnetic resonance imaging | 90 days |
| Glutamate concentration in the anterior cingulate cortex and left dorsolateral prefrontal cortex | Proton spectroscopy - magnetic resonance imaging; Glutamate concentration in the left dorsolateral prefrontal cortex will be correlated to over all measures of cognition and executive functioning. | 90 days |
| Cognition | Instrument: Wechsler Adult Intelligence Scale (WAIS) version 3. Subscale: Full Scale Intelligence coefficient. Mean: 100 Standard deviation (SD):15 for Brazilian population. Range of classification: 69 and below - Extremely Low 70-79 - Borderline 80-89 - Low Average 90-109 - Average 110-119 - High Average 120-129 - Superior 130 and above - very superior | 90 days |
| Operational memory | Subscale from Wechsler Adult Intelligence Scale (WAIS) version 3. Mean: 100 Standard deviation (SD):15 for Brazilian population. 69 and below - Extremely Low 70-79 - Borderline 80-89 - Low Average 90-109 - Average 110-119 - High Average 120-129 - Superior 130 and above - very superior | 90 days |
| Verbal memory | Rey Auditory-Verbal Learning Test (RAVLT). Mean and range for Brazilian population:
| 90 days |
| Language (Verbal Fluency) | Verbal Fluency Tests: (FAS) and Animals. Mean and standard deviation (SD) according to age range and years of education: Age range for the test: 16-59 years Score classification according to years of education:
Mean: 44.7 SD:11.2 Range in Z-scores: Z <-1.5 are classified as deficit; Z >-1.5 are expected | 90 days |
| Executive function | Stroop Test -Victoria Version. Mean and standard deviation (SD) according to the age range and years of education: For 19-39 years old + 5-8 years of education: Mean: 33.3 SD:11.35 For 19-39 years old + 9 or more years of education: Mean: 41.73 SD: 9.85 For 40-59 years old + 5-8 years of education: Mean: 28 SD: 7.76 For 40-59 years old + 9 or more years of education: Mean: 37.17 SD: 9.98 Range in Z-scores: Z <-1.5 are classified as deficit; Z >-1.5 are expected | 90 days |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |