Cross-sex Hormone Therapy and Neuronal Plasticity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-13

Study Completion Date

2019-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gender Dysphoria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Sel-controlled case series

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transgender Women

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.

Group Type EXPERIMENTAL

Estradiol

Intervention Type DRUG

Induced hypogonadism and re-institution of CSHT

Interventions

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Estradiol

Induced hypogonadism and re-institution of CSHT

Intervention Type DRUG

Other Intervention Names

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Drug washout

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes