Cross-sex Hormone Therapy and Neuronal Plasticity

August 27, 2018 updated by: Hospital de Clinicas de Porto Alegre

Neuroactive Sex Steroids And Their Influence In Glutamatergic Neurotransmission - Effects in Memory and Cognition in Transgender People

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Estradiol
Induced hypogonadism and re-institution of CSHT
Other Names:
  • Drug washout

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glutamate concentration in the left hippocampus
Time Frame: 90 days

Proton Spectroscopy - magnetic resonance imaging;

Glutamate concentration in the left hippocampus will be primarily correlated to working memory scores.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortical Thickness
Time Frame: 90 days
Anatomical magnetic resonance imaging
90 days
Diffusion track imaging
Time Frame: 90 days
Micro-Structural magnetic resonance imaging
90 days
functional connectivity
Time Frame: 90 days
functional magnetic resonance imaging
90 days
Glutamate concentration in the anterior cingulate cortex and left dorsolateral prefrontal cortex
Time Frame: 90 days
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
Time Frame: 90 days
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
Time Frame: 90 days
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
Time Frame: 90 days

Rey Auditory-Verbal Learning Test (RAVLT). Mean and range for Brazilian population:

  1. A1 (Verbal Memory - Immediate recall). Range (in Z-scores): Z <-1.5 are classified as deficit; Z >-1.5 are expected
  2. A5 (Verbal Memory - immediate recall). Range (in Z-scores): Z <-1.5 are classified as deficit; Z >-1.5 are expected
  3. A7 (Verbal Memory - late recall). Range in (Z-scores): Z <-1.5 are classified as deficit; Z >-1.5 are expected
  4. Learning Over Trial (LOT) (Learning capacity). Range (in Z-scores): Z <-1.5 are classified as deficit; Z >-1.5 are expected (please, note the reference for Brazilian population in the section "references" where the mean and standard deviation according to Brazilian population are described for each of the subtest; Salgado et al. (2011).
90 days
Language (Verbal Fluency)
Time Frame: 90 days

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:

  1. From 0 to 8 years of education:

    Mean: 38.8 SD: 12.0

  2. From 9 to 12 years of education:

    Mean: 40.5 SD: 10.7

  3. From 12 to 21 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
Time Frame: 90 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Maria Lobato, Dr, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2017

Primary Completion (Anticipated)

March 30, 2019

Study Completion (Anticipated)

March 30, 2019

Study Registration Dates

First Submitted

August 24, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150199a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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